Total 35 Manager quality assurance job vacancies in D05 Clementi New Town, Hong Leong Garden, Pasir Panjang

About Us

Vivo Surgical is a patient-focused, clinician-driven medical device developer and manufacturer. Headquartered in Singapore with offices in China and Thailand, we are pioneering a novel endoscopic surgical robot for complex endoluminal surgeries. ISO 13485 certified with international accreditations awarded such as the US FDA and European CE mark, our devices target the medical needs of the world through innovative applications of science & technology. These encompass such fields as in vivo surgical LED lighting, portable endoscopy and endoscopic robots, which are strategically co-developed with world-class healthcare institutions and KOL collaborators. Join us as we build towards our vision of being Asia Pacific’s leading medical device developer and manufacturer.

About The Role

We value the importance of having a robust Quality Assurance and Regulatory Affairs team that would serve as a key pillar for sustained commercial success. To that end, we are looking for a Quality Assurance & Regulatory Affairs Manager to join us on this journey. You will be part of our fast-growing team and will take ownership of your role from the get-go. You will work on ensuring our company’s commitment to comply with regulatory requirements and to maintain the effectiveness of our Quality Management System (QMS). You will also be in charge of our products’ regulatory strategies and submissions to various regulatory bodies. Your role will enable you to work not only with diverse functions internally but also in close tandem with our external partners such as our suppliers, distributors and notified bodies.

Your responsibilities shall include the following:

• Ensure the company’s QMS complies with ISO 13485 and FDA 21 CFR 820/QMSR.
• Develop and manage Quality Procedures such as document control, CAPA, NCR, Supplier Control, Production Control, Feedback and Complaints Handling, and Post Market Surveillance.
• Organize and execute internal audits, management reviews and supplier audits.
• Plan and lead ISO 13485 audits and regulatory inspections.
• Participate in the products’ verification and validation activities.
• Develop, review and compile the medical device technical files whilst making sure the products meet all regulatory and quality standards.
• Involved in risk assessment tasks to identify potential quality and compliance risks in the product lifecycle and advise adequate risk control measures.
• Serve as the company’s Quality Management Representative (QMR) and Person Responsible for Regulatory Compliance (PRRC).
• Manage and mentor the QARA team to ensure members are adequately trained.
• Stay updated on medical device laws and regulations in the targeted markets.
• Work with senior management to define and deliver adequate quality and regulatory strategies.

Your Qualifications & Experience

• Minimum Bachelor’s degree in Engineering or Science.
• At least 5 years’ experience in quality assurance and/or regulatory affairs in the medical device Industry.
• Firm understanding of ISO 13485:2016, FDA 21 CFR 820/QMSR and ISO 14971.
• Prior involvement in HSA, FDA 510(k)/De Novo and/or MDR 2017/745 submissions will be a plus.
• Experience in generating risk management documentation (risk management plan, report, FMEAs).
• Possess a leadership and strategic mindset to organize and prioritize tasks for effective and timely delivery of regulatory goals to meet the company’s business objectives.
• Certification as an ISO13485:2016 lead auditor will be advantageous.

Contact

Please send your CV and cover letter to: [email protected]. We look forward to receiving your application.

The primary responsibility of this position is to provide leadership for all Quality Assurance & Control matters.

This includes:

• Assuring consistent quality of production by developing processes and enforcing compliance to ISO 13485 quality system.
• Validating the production & inspection processes and maintaining validation status
• Managing the records for Quality Inspection, Quality Control, Calibration, QA Lab equipment, Training Resources, ERP Quality Module and Quality System Documentation.
• Managing a team of Engineers, QA Technicians & Quality Inspectors

The incumbent reports to the Site Leader, Singapore and Global Head of Quality (Medevio).

Roles & Responsibilties

Quality System Management

• Manage and maintain the site's quality management system (QMS) in compliance with ISO 13485 and ISO 9001 and applicable regulatory standards.
• Key stakeholder in ERP in Quality Module and DMS of site
• Ensure that the QMS effectively supports all manufacturing and operational processes, resulting in consistently high-quality product outputs.

Quality Operation & Lab Management:

• Oversee the day-to-day operations of the quality control and assurance, ensuring proper procedures and outcomes that consistently align with product specifications.
• Manage a team on quality inspection and establishing protocols fulfilling both internal, external customers.
• Develop and enforce rigorous lab testing protocols to maintain stringent quality and safety standards.

Capital Expenditure Planning and Equipment Management:

• Plan and manage capital expenditure for quality-related equipment in production to support ongoing and new operations.
• Site calibration SME and coordinator for both internal and external calibration.
• Ensure timely maintenance and calibration of quality equipment to maintain operational efficiency and compliance with industry standards.

NPI and quality engineering:

• Ensure compliance with new and pre-existing product requirements.
• Key stakeholder in new product development including qualification to production readiness.

Global Quality:

• Working with Global Head of Quality to drive Global Quality Plan
• Working with peers in Global Quality to drive strategic global initiatives, ensuring cohesive quality management across Medevio Sites

Regulatory Compliance and Auditing:

• Oversee readiness for all internal and external audits, including customer audits and third-party regulatory audits.
• Lead the preparation and submission of documentation required for regulatory compliance in all markets where products are distributed.
• Develop and implement strategies to manage and reduce compliance risks.

Supplier Management and Incoming Quality Control:

• Oversee supplier quality management, conducting audits and addressing issues to ensure supplier compliance with quality standards.
• Develop and maintain strong relationships with suppliers to ensure continuous supply chain improvement and adherence to quality specifications.

Quality Improvement Initiatives:

• Identify opportunities for process improvements and lead quality improvement projects to enhance manufacturing efficacy and product quality.
• Drive the transformation towards a paperless factory to enhance operational efficiency and data integrity.
• Implement Statistical Process Control (SPC) to monitor and control quality during manufacturing processes.
• Utilize digital tools and methodologies such as Six Sigma and lean manufacturing to improve productivity and product quality.

Team Leadership and Development:

• Manage and lead a team of skilled quality engineers and technicians, providing strategic direction, training, and development.
• Foster a culture that prioritizes quality and compliance through continuous training, learning and development programs, and succession planning.

Stakeholder Engagement and Reporting:

• Align with the global quality function on strategic global initiatives, ensuring cohesive quality management across the organization.
• Collaborate closely with manufacturing, R&D, and supply chain departments to ensure alignment on quality standards and to address quality issues promptly.
• Report on quality metrics and KPIs to senior management, providing insights and recommendations for ongoing quality enhancements.
• Communicate effectively with customers and regulatory bodies regarding product quality and compliance issues.

Complaint and CAPA Handling:

• Lead the investigation and resolution of non-conformance issues and product incidents, identifying root causes and implementing corrective actions.
• Manage the customer complaint process, ensuring all complaints are addressed promptly and effectively.
• Lead the development and completion of 8D reports, ensuring thorough documentation and effective resolution of issues.
• Oversee the implementation of corrective and preventive actions (CAPA) to eliminate the causes of potential non-conformities or issues, preventing their recurrence.

Environmental Health and Safety (EHS) and Sustainability:

• Support the development, implementation, and enforcement of an EHS policy, complying with all legal and corporate policies.
• Assist in fostering a culture of safety responsibility, providing ongoing training and resources to ensure a safe and healthy work environment.
• Support the establishment and execution of site ESG goals in alignment with Medevio's global sustainability roadmap, ensuring the site contributes effectively to broader corporate sustainability targets.

Qualifications

• Bachelor’s in Engineering or Science / Master’s in Engineering or Science
• Extensive experience within a manufacturing environment with a thorough understanding of ISO 13485 and ISO 9001.
• Six Sigma certification and/or ASQ certified Quality Engineer

Overview

The Job Holder will support in building improvement capabilities and culture in the NUHS Regional Health System Office (RHSO), including community partners such as GPs. The Job Holder will be involved in co-developing and conducting quality improvement training for RHSO staff and community partners, as well as facilitate and coach small to large scale improvement projects through the use of appropriate tools/methodologies.

Job Responsibilities

1. Deliver QI Training

• Develop training materials and resources (e.g. training guides and e-learning videos) on quality improvement
• Conduct and facilitate quality improvement training sessions/workshops for RHSO staff and partners
• Gather feedback on training sessions and use of appropriate improvement methodologies/tools
• Deliver training on lean management and human-centred tools to impart knowledge and skills to hospital staff.

1. Facilitation of improvement projects

• Facilitate and coach department/division and organisation-wide level improvement projects to improving quality and processes through the use of appropriate tools/methodologies
• Monitor the progress of improvement activities and guide teams to take appropriate actions
• Assist in interpreting data to measure the effectiveness of the improvement activities

1. Strategy & Culture Building

• Assist in development and implementation of Improvement framework and strategies
• Support initiatives or events that promote improvement and Innovation culture in RHSO
• Lead engagement with HODs to influence and identify areas of improvement in quality and safety

1. Any other tasks as assigned

Requirements

Qualification Required and Area of Discipline

Good degree in any discipline, preferably in Life Sciences, Business Administration, Industrial Design

Prior healthcare sector experience is preferred

Required Competencies and Capabilities (Skills, Experiences and Professional Licences)

• Proficient in quality improvement methodologies such as Lean, process/value-stream mapping, design thinking
• At least 1-2 years of experience in facilitating workshops and conducting trainings
• Confident in coaching and guiding fellow colleagues in Quality Improvement tools
• Certified Six Sigma Green/Black Belt will be an added advantage
• Able to engage stakeholders and work through doctors, nurses, allied health professionals, operations and administrative staff
• Able to work independently and as a team
• Ability to perform even under tight timelines
• Good analytical and organization skills
• Good writing and verbal communication skills
• Open to learning and trying new things. Able to grasp concepts easily and be able to think on the feet.
• Highly self-driven and self-motivated, positive attitude and perseverance to overcome obstacles

Get to Know the Role

We are seeking a Senior Manager of Application Engineering & QA to lead a team in providing innovative technical solutions while ensuring quality standards. This role involves overseeing continuous improvement projects, mentoring team members, and collaborating with customers on their technical needs. Additionally, the candidate will handle customer inquiries and manage audits. Knowledge of quality assurance practices and strong leadership and communication skills are essential.

Essential Responsibilities

· Lead a team of Application Engineers to meet company objectives and KPIs while planning and managing Continuous Improvement Projects (CIP) focused on quality, safety, and budget adherence.

· Supervise the design and implementation of technical solutions to meet customer needs.

· Coordinate with product development, sales, and support teams for seamless integration.

· Execute and monitor Application Engineering projects to ensure timely and budget-compliant delivery while staying informed on industry trends and technologies to provide innovative solutions.

· Collaborate with different stakeholders and Japanese counterparts to resolve customer feedback.

· Oversee the development of technical documentation and train users on best practices.

· Ensure compliance with quality assurance practices and industry standards.

· Manage customer audits to uphold quality protocols and address any findings.

· Provide coaching and development opportunities to enhance team performance.

Skills and Competencies Profile

· A Master’s or Bachelor’s degree in Engineering.

· 6 to 8 years of relevant experience, including 2 to 4 years in a managerial role.

· In-depth knowledge of thin-film metallurgy, deposition processes, and related equipment (e.g., Ion Beam Deposition, PVD, CVD).

· Proficient in problem-solving, with the ability to address customer issues through critical and logical thinking

· Familiarity with quality assurance practices, including compliance with industry standards and quality management systems.

· Experience in conducting audits and implementing corrective actions to ensure adherence to quality protocols.

· Proficiency in statistical data analysis tools such as JMP, Minitab, Design of Experiments (DOE), and Statistical Process Control (SPC).

· Strong leadership, coaching, and communication skills.

· Ability to thrive in a dynamic, fast-paced environment while managing multiple priorities.

HOYA Electronics Singapore Pte Ltd is an equal opportunity employer. We are committed to building diverse teams and creating a safe and inclusive workplace that enables our people to perform at their best, regardless of nationality, ethnicity, religion, age, gender identity or sexual orientation, and other attributes that make every individual unique.

An offer with HOYA Electronics Singapore is conditioned upon the successful completion of pre-employment conditions, as applicable, and subject to applicable laws and regulations.

HOYA Electronics Singapore does not charge candidates any recruitment fees or unlawfully collect any other payment from candidates as consideration for their employment with HOYA Electronics Singapore.

Primary Purpose

Reporting to the Senior Manager, Supply Chain SMO/COE, the Master Data Quality & Governance Manager plays a vital role in ensuring the accuracy and integrity of master data and will be responsible for overseeing and implementing data governance strategies, policies, practices, and processes across the Asia Pacific region. This role is also responsible for collaborating with APAC business stakeholders to understand their data needs and requirements and ensuring data quality standards, processes and procedures align with business objectives, and providing training and support to business stakeholders on data quality best practices.

Develop and Implement Data Governance Framework:

o Design and establish a comprehensive data governance framework across the Asia Pacific region.

o In partnership with Global Data Governance teams define data governance policies, procedures, and standards to ensure consistent and accurate data management practices.

o Collaborate with stakeholders to gain buy-in and support for the data governance initiatives.

Data Stewardship and Ownership:

o Establish data quality rules, monitor data compliance, and resolve data-related issues.

o Ensure data ownership and accountability by establishing data governance and execution roles and responsibilities.

o Drive continuous improvement by monitoring data governance performance and identifying opportunities for enhancement.

o Conduct regular data audits and assessments to identify gaps and recommend corrective actions.

o Collaborate with cross-functional teams, including IT, finance, operations, privacy and legal to ensure alignment and compliance with data governance initiatives.

o Engage with global stakeholders to share best practices, leverage synergies, and contribute to the overall data governance strategy.

Training and Awareness:

o Develop training programs and materials to educate employees on data governance policies, procedures, and best practices.

o Raise awareness of the importance of data governance and its impact on business operations and decision-making.

o Provide guidance and support to business units in implementing data governance practices effectively.

o Act as a subject matter expert, providing guidance and support to stakeholders on data governance-related matters.

Inherent Requirements

Formal Qualifications

Bachelor's in information management, computer science, business administration, or a related field.

Key Skills / Core Competencies

• Strategic thinking ability, as well as detailed analytical and problem-solving skills
• Strong communication and relationship building skills to collaborate cross functionally with internal partners and external customers.
• Comfort in managing relationships with senior leadership.
• Strong entrepreneurial, customer service orientation.
• Ability to effectively prioritize, execute tasks and manage deadlines in a high-pressure environment.
• Good written, oral, and interpersonal communication skills.
• An ability to work well in an ambiguous environment with minimum supervision.
• Strong professional presence and business acumen.
• Innovative, proactive, and flexible to change.
• Self-motivation and a strong sense of ownership and accountability
• Exposure to process improvement methodologies with Lean Six sigma Green or Black belt an advantage

Experience

• Proven experience in data governance, data management, or related roles, preferably within a multinational organization operating in the Asia Pacific region.
• In-depth knowledge of data governance frameworks, principles, and best practices.
• Strong understanding of data quality management, data privacy regulations, and data-related compliance requirements.
• Demonstrable experience leading process change
• Superior vendor management experience
• Demonstrable knowledge and experience in SAP, SFDC, M365, BI and data analysis tools.

Job Duties:

• Manage the process for QMS audits, to ensure compliance of the organization’s Integrated Management Systems wrt ISO9001/TS16949/ VDA 6.3, Customer specific requirements.
• Identify areas/ system gaps for improvement and implementation. Establish and drive QMS enhancement and integration roadmap/milestones.
• Work closely with Operations and key stakeholders to maintain consistent manufacturing, quality policies and compliance
• Responsible for maintaining/improving fab performance though SPC program.
• Investigate root causes and resolve key fab-related quality issues and effectiveness of corrective and preventive actions. Manage Non-Conformance cases with respect to on-time closure with the relevant customers/Business Lines.
• Responsible for Outgoing and Periodic review OQA performance to drive defect reductions
• Responsible for Document Centre Management & Library Services
• Management of change among diverse cultures in a fast paced environment
• Co-work with related functions to support the wafer fabrication process to drive process/system optimization and effectiveness

Job Qualifications:

• Degree in Chemical / Electrical Engineering / Physics / Chemistry or equivalent
• 8+ years in semiconductor industry preferred
• Knowledge of wafer fabrication process essential
• Strong in project management skills, facilitation, analytical skills and system thinking

Job Description & Responsibilities:

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Work with technical team to create quality document related to product design, development and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Develop and evaluate medical device regulatory intelligence and maximize opportunities to expedite the registration process within S.E.A region, China and USA. Activities include obtaining and maintaining domestic and regional market access for our innovative products.
• Provide appropriate inputs to assist in defining regulatory strategies and timelines for regulatory submissions for the total product lifecycle for medical devices.
• Compile technical, clinical and production protocols and documentations necessary for new products dossier submission to S.E.A. region, China and USA. regulatory submissions. Liaise with technical team (locally and internationally) on technical information required to prepare submission dossiers. Manage preparation (developing submission content, management of document legalization, and creation of any other documents required for submissions) and maintenance of regulatory submissions and other premarket registrations to acquire appropriate commercial distribution clearances in accordance with regulatory strategic plan.
• Overall responsible for ensuring that medical device files are set up in compliance to regulatory requirement.
• Monitor and communicate new and changing medical device law, guidance regulations in a timely manner. Reviews process change recommendation and assists in implementing new procedures and documentation.
• Ensure that regulatory records are controlled and maintained.
• Train internal and external stakeholders on regulatory data management processes and platforms, regulatory matters and product registration.

Job Requirements:

• Master or Bachelor of Science/Engineering with strong background in biomedical, computer or engineering sciences.
• Possess 3 years or more of working experience in quality assurance and regulatory affairs in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge of Health Sciences Authority requirement for IVD product submission.
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Experience with product registration submission and evaluation.
• Experience with maintaining internal regulatory database.
• Experience with Dossier Creation.
• Ability to develop and implement plans for regulatory submission.
• Awareness of applicable workplace environment, health and safety regulations.
• Ability to network and build strategic partnership with good problem solving skills and communication skills.
• Possess leadership and agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Get to Know the Role

We are seeking a Senior Manager of Application Engineering & QA to lead a team in providing innovative technical solutions while ensuring quality standards. This role involves overseeing continuous improvement projects, mentoring team members, and collaborating with customers on their technical needs. Additionally, the candidate will handle customer inquiries and manage audits. Knowledge of quality assurance practices and strong leadership and communication skills are essential.

Essential Responsibilities

· Lead a team of Application Engineers to meet company objectives and KPIs while planning and managing Continuous Improvement Projects (CIP) focused on quality, safety, and budget adherence.

· Supervise the design and implementation of technical solutions to meet customer needs.

· Coordinate with product development, sales, and support teams for seamless integration.

· Execute and monitor Application Engineering projects to ensure timely and budget-compliant delivery while staying informed on industry trends and technologies to provide innovative solutions.

· Collaborate with different stakeholders and Japanese counterparts to resolve customer feedback.

· Oversee the development of technical documentation and train users on best practices.

· Ensure compliance with quality assurance practices and industry standards.

· Manage customer audits to uphold quality protocols and address any findings.

· Provide coaching and development opportunities to enhance team performance.

Skills and Competencies Profile

· A Master’s or Bachelor’s degree in Engineering.

· 6 to 8 years of relevant experience, including 2 to 4 years in a managerial role.

· In-depth knowledge of thin-film metallurgy, deposition processes, and related equipment (e.g., Ion Beam Deposition, PVD, CVD).

· Proficient in problem-solving, with the ability to address customer issues through critical and logical thinking

· Familiarity with quality assurance practices, including compliance with industry standards and quality management systems.

· Experience in conducting audits and implementing corrective actions to ensure adherence to quality protocols.

· Proficiency in statistical data analysis tools such as JMP, Minitab, Design of Experiments (DOE), and Statistical Process Control (SPC).

· Strong leadership, coaching, and communication skills.

· Ability to thrive in a dynamic, fast-paced environment while managing multiple priorities.

HOYA Electronics Singapore Pte Ltd is an equal opportunity employer. We are committed to building diverse teams and creating a safe and inclusive workplace that enables our people to perform at their best, regardless of nationality, ethnicity, religion, age, gender identity or sexual orientation, and other attributes that make every individual unique.

An offer with HOYA Electronics Singapore is conditioned upon the successful completion of pre-employment conditions, as applicable, and subject to applicable laws and regulations.

HOYA Electronics Singapore does not charge candidates any recruitment fees or unlawfully collect any other payment from candidates as consideration for their employment with HOYA Electronics Singapore.

Job Description & Responsibilities

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Ensure the overall document control system supports the QMS.
• Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Lead auditor for internal and external audits.
• Conduct management review, ensure QMS stays current and relevant.
• Lead in root cause analysis and CAPA.
• Analyze trends inquality performance.
• Drive improvement in the quality management system.

Job Qualifications

• At least a Master's degree in Science/Engineering or relevant related field.
• Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Strong background in biomedical, computer or engineering sciences.
• Awareness of applicable workplace environment, health, and safety regulations.
• Possess creative skills and problem-solving skills.
• Adeptness in cultivating professional networks and build strategic partnerships.
• Good communication skills.
• Demonstrates strong leadership capabilities and an agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

Job Description & Responsibilities

• Maintenance of Quality Management System ensuring compliance to internal, and international standards and regulatory requirements for medical devices.
• Develop QMS documents in line with business activity of DxD Hub.
• Ensure the overall document control system supports the QMS.
• Work with technical team to create quality document related to product design, development, and manufacturing, including product test/validation protocols, change management in compliance to applicable regulatory requirements.
• Lead auditor for internal and external audits.
• Conduct management review, ensure QMS stays current and relevant.
• Lead in root cause analysis and CAPA.
• Analyze trends inquality performance.
• Drive improvement in the quality management system.

Job Qualifications

• At least a Bachelor’s degree in Science/Engineering or relevant related field.
• Possess at least 4 years of working experience in quality assurance in medical devices; thorough working knowledge of ISO 13485:2016.
• Good working knowledge in managing QMS in a medical device environment in compliance to ISO 13485:2016.
• Competent in quality assurance methodologies.
• Working knowledge in QA processes for design, development, and manufacturing of IVD, SaMD and Integrated Medical Technologies.
• Demonstrated skills in risk management (ISO 14971).
• Knowledge in regulatory requirements for medical devices in ASEAN, USA and EU.
• Strong background in biomedical, computer or engineering sciences.
• Awareness of applicable workplace environment, health, and safety regulations.
• Possess creative skills and problem-solving skills.
• Adeptness in cultivating professional networks and build strategic partnerships.
• Good communication skills.
• Demonstrates strong leadership capabilities and an agile mindset.

The above eligibility criteria are not exhaustive. A*STAR may include additional selection criteria based on its prevailing recruitment policies. These policies may be amended from time to time without notice. We regret that only shortlisted candidates will be notified.

We are looking for a Quality Control Manager.

Job Description:

• Inspect in-coming and outgoing products according to policies standard.
• Manage inhouse and supplier’s quality (Lightings and Event Logistics Items)
• Establish standard operating procedures and conditions for handling storage and checklist of stock.
• Perform other ad-hoc duties as assigned.

Requirements

• Basic understanding of production methods for decoration lightings and Event logistics
• Attention to detail
• Good Communication and Interpersonal Skills
• Able to multi-task and quick learner

Responsibilities:

• Lead and execute comprehensive audits for both listed companies and SMEs, locally and internationally, from planning through to completion, consistently meeting deadlines while demonstrating reliability and strong organizational skills as a key team member.
• Develop and apply effective problem-solving skills, providing actionable recommendations to management based on thorough industry research, insightful analysis, and investigative findings.
• Show initiative and uphold a strong work ethic, coaching junior staff, sharing knowledge, and understanding how individual contributions impact team performance and outcomes.
• Understand the role of the business unit within the broader firm context, actively building internal networks, and making meaningful contributions during client meetings alongside senior team members.

Requirements:

• Min Degree or professional accounting qualifications recognised by ISCA
• Minimum 2 years’ relevant experience with large/mid-tier international accounting firms
• Proactive, committed and able to work under pressure
• Possess initiative and the ability to work independently
• Team player

If you are interested, kindly apply through mycareersfuture.

I regret to share that only shortlisted candidates will be notified.

www.dadaconsultants.com

EA Registration Number: R21100604

Data provided is for recruitment purposes only

Business Registration Number: 201735941W.

Licence Number: 18S9037

Job description:

1. To plan, organize and monitor all activities relating to quality assurance to maintain quality standards and systems to meet customer requirements.

2. To define and control the characteristics of each part, affiliated with appropriate Inspection Plans; and make available the required facilities to verify these characteristics.

3. To oversee and approve First Article inspection procedures prior to sample submission to customers.

4. To issue material certificate to meet customer requirements.

5. To liaise with customers on matters related to quality.

6. To conduct/co-ordinate Material Review procedures to implement any Corrective/Preventive Action; and follow-up for a closure with result of satisfactory action taken.

7. To approve disposal of non-conforming items.

8. To ensure all inspections are conducted correctly.

9. To control and manage the Equipment Calibration System; setting the frequency of each calibration.

10. To report quality performance and critical discrepancy issues to General Manager.

11. To propose to General Manager an indicative rate of annual salary-increment and annual bonus of his subordinates reflected through the past year performance.

12. To approve the application of various type of Leave of his subordinates.

13. To approve petty-cash paid to his subordinates.

14. To recruit and upgrade his subordinates with relevant training programs and sue practical experiences.

15. To train subordinates in Sampling and Inspection techniques.

Experience Required:

At least 5 years experience in a Quality Control Management.

Skills required

1. Well-versed in ISO 9001:2000 requirement.

2. Quality Control System.

Qualification required

1. Mechanical/Manufacturing/Engineering Degree.

IT Exposure

1. Computer literate in MS Office.

2. Application knowledge in Autocad.

• Position : Quality Manager – Up to $8,000 – Changi South
• Location : Changi South
• Working hours : 5 Days Work Week – Monday to Friday: 7.30AM to 4.30PM
• Salary (commensurate with experience) : Up to $8,000 Basic + Transport Allowance + AWS + Performance Bonus + 12 Days Annual Leave + Medical & Dental Benefits
• Duration : Perm
• Industry : Industrial Gas

Responsibilities:

• Lead the Quality Department to implement effective quality assurance and control processes to ensure that the product delivered meet customers’ requirement and achieves company quality
• objectives.
• Ensure compliance to customers’ requirements throughout the organization.
• Collaborate with the Management Team and Stakeholders to define and implement the Company’s Quality Strategy.
• Manage and continuously improve company's Quality Systems in compliance with Company’s policies and standards and to industry standards such as AS9100 and NADCAP.
• Review, prepare, administer and implement Quality Assurance Plans, Inspection Test Plans and other operational procedures in accordance with the technical specifications, customer's needs
• and requirements, and good manufacturing / engineering practices.
• Define, monitor and report Company’s key performance indicators such as On-Time Delivery, First Pass Yield, Cost of Poor Quality and use these metrics for continuous improvement of Quality.
• Work closely with all departments to meet goal of 100% On-Time Delivery, Zero Defects on all customers’ orders.
• Lead internal team to resolve Quality escalation from customers through systematic root cause analysis frameworks for efficient, effective and timely corrective actions.
• Drive continuous improvement programs such as annual Quality planning, Lean Six Sigma improvement projects, Quality audits, etcetera to achieve Operational Excellence.
• Implement risk assessment systems for all critical control points in the whole quality process flow.
• Implement and maintain a system of auditing the facility and periodic calibration of test, measuring equipment and tools.
• Liaise with vendors on purchase and calibration of production equipment, gauges and Quality consumables.
• Develop and continuously build staff competencies, skills and knowledge through competency gap analysis and team members’ career progression and development plan.
• Identify and integrate relevant QA software into existing quality process flow to increase work efficiency and productivity.
• Support sales team when required by working together to liaise with external customers and stakeholders to deliver timely corrective actions.
• Report to top management on the performance of the quality management system and initiatives towards improvement.

Requirements:

• Minimum Degree in Mechanical / Materials Engineering with minimum 5 years’ experience
• Proven experience as Lead auditee in industry regulations.

Email to: [email protected]

Do visit www.facebook.com/search.personnel and https://www.instagram.com/search.personnel for more job listings and career tips!

***We do not charge our candidates any referral fee nor bind them with any contract.***

Jeslyn Tan

Associate Consulting Director (APAC)

Reg no.: R21101247 | EA No: 13C6684

Thank you for your interest in this position. Our shortlisting period is 3 working days. Only shortlisted candidates will be contacted for further consideration.

If you do not receive communication from us within this timeframe, it's likely that your application has not been shortlisted by our client. In such cases, we recommend that you continue your job search to maximize your opportunities. We wish you all the best and should we have any suitable roles that match your experiences/ qualifications/ preferences, we will reach out to you.

Job Description

Job Scope & Responbilities :

* Handle for full set of account

* Financial month end closing

* Coordinate and liaise with external parties like auditors, tax agents and tax authorities

* Responsible for all duties related to Human Resources,

* Monthly payroll preparation, CPF submission

* Responsible of IRAS AIS,IR8A, Corporate tax, Income tax etc.

* MOM WPOL/EPOL/ matter

* Handling other admin duties

* Perform any other ad hoc duties when required.

Job Requirements :

* Candidate must possess at least diploma or equivalent.

* Language: Bilingual in English and Chinese Mandarin (read, write and speak) as the incumbent needs to liaise with Mandarin-speaking associates in the course of work.

* At least 2 Year(s) of working experience in the related field is required for this position.

Key Responsibilities:

The main responsibilities are:

• Pasir Ris Quality Transformation Project: Develop and propose target operations model for Plant Quality Singapore
• Align with QP Bernin future operations model
• Achieve local and global stakeholders alignment and buy in
• Define deployment plan and execute (including management system and reporting)
• Update respective procedures and documentation
• Assess Quality resources: Competencies, HC, performance and propose way forward to fit to the proposed target operations model
• Define training, competency management plan and execute within agreed budget boundaries
• Drive Quality improvement project

Requirements:

• Demonstrating excellent communication and the ability to communicate well with peers and various stakeholders locally and on a remote basis
• Keeping up with a fast paced international company, being resourceful and independant
• You are open-minded and cross cultural agile
• Strong problem-solving skill, independent team player and good interpersonal skills
• Initiative, responsible, and positive attitude
• Meticulous and able to work in a fast-paced environment

Roles & Responsibilities

Cellvec Pte Ltd is currently looking for an experienced & Passionate QA professional who can fully support our clinical and commercial GMP manufacturing of Cell & Gene Therapy Products.

This role will provide you the opportunity to lead key activities to progress your career, these responsibilities include some of the following:

• Lead a team of QA professionals to manage and oversee all the areas of GMP operations. Always ensure inspection readiness.
• Effectively manage Change controls, Deviations, OOS, QRM, Document management, Trainings, Audits, Batch release, Qualifications & Validations, Business support, Trends & Reports, Annual Product quality review etc
• Supports regulatory and client audits as Quality subject matter expert.
• Provide QA expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill/APS protocols and reports, validations, Qualifications, Environmental monitoring, Risk assessment and specifications.
• Strategize, plan and organise the team's resources to perform operations.
• Plan and develop working knowledge and stakeholder management of the team of Quality professionals.
• Promote the Quality culture on Site through exemplary behaviours.
• Ensures the implementation of adequate training for aseptic gowning, aseptic qualification, practices and QA observations.
• Participates in review of policies and policymaking.
• Ability to communicate quality operations and compliance perspective effectively to senior management.
• Understands and articulates company business strategy. Maintains a broad view of the business recognizes changes and trends in the appropriate area in which the individual operates.
• Responsibility to drive the focus on safety to the QA staff and into functional areas that routinely support CT/GT manufacturing.
• Any other tasks as and when assigned by the Supervisor.

Ideally, we are looking for candidates with these criteria’s:

• Minimum of Degree in Biochemistry/Microbiology/Biotechnology discipline. Master degree and above are preferred.
• A minimum of 10 years’ experience in the pharmaceutical/Biotech industry, preferably in CGT manufacturing and its GMP compliance.
• Demonstrated experience with helping operations to prepare for Regulatory GMP inspection. Experience managing HSA, USFDA, EU & Client audits are preferred.
• Experience in leading internal, External and regulatory audits. Experience formulating the audit responses and CAPA
• In-depth understanding of cGMP regulations and regulatory requirements of Biotech/Cell and gene industry.
• Strong experience, Extensive knowledge and hands-on experiences of handling Sterile pharmaceutical/Biotech manufacturing processes.
• Ability to apply optimal quality assurance standards to promote a business edge.
• Ability to facilitate business activities compatible to international regulatory environment.
• Ability to communicate effectively within the site organization and across the network.
• Good people management skills.
• Good risk management skills.
• Good Analytical thinking skills.
• Hands on experience in Working with Aseptic environments.
• Exposure in handling Quality Management Systems.
• Exposure in ensuring GLP compliance in QC Laboratory.

COMPANY DESCRIPTION

Founded in Singapore in 2004, Akribis Systems is a motion control company that provides high precision direct drive motors. We construct products for a range of industries including renewable energy, semiconductor, communication, biomedical, robotics or any industry that requires precise motion.

We produce direct drive motors with a high force density and patented coil design that decreases cogging. Our linear and rotary motors also are available with stages that we manufacture ourselves so you can smoothly integrate the motor into your design.

More than simply a manufacturer, we are also innovators. Our deep knowledge of engineering and dedication to the work has resulted in 92 patents, and our research and development into the field of magnetics will only continue to grow our business. Our engineers are able to custom design motors and stages to your specific requirements with you as a co-developer.

Today, we have five production factories and numerous sales and support offices across the globe. At Akribis Systems, precision matters.

RESPONSIBILITIES

• Track in-process quality-related issues and incidents in master issue list and periodically report on trends, insights, and closure status to BU management.
• Understand and classify issues into discipline such as quality, operational, design, etc.
• Host post-mortem discussion during each project closure to review issues and identify preventive action plan for each issue.
• Participate in manufacturing departments to track non-conformance reports filed during buy-off process and define preventive action plan.
• Champion long-term quality improvement efforts (new processes, structural changes, training, etc.) within the business unit to increase metrics such as first-pass yield and number of quality-related returns.
• Track and investigate quality-related returns and customer complaints with a view to long-term prevention.
• Coordinate First Article Inspection Process for new manufacturing processes or parts
• Lead continuous improvement initiatives to enhance product quality, reduce waste, and improve operational efficiency.
• Identify and implement process improvements based on lean manufacturing principles
• Supervise and mentor the quality assurance team, providing guidance and support to ensure their professional development.
• Foster a culture of quality and continuous improvement within the organization.
• Ensure the manufacturing facility maintains ISO certification.
• Coordinate and oversee all ISO-related activities, including internal and external audits.
• Act as the main point of contact for ISO certification bodies.
• Serve as the Management Representative (MR) for the QMS.
• Report to top management on the performance of the QMS and any need for improvements.
• Ensure the promotion of awareness of customer requirements throughout the organization.

• 5 - 8 years' experience working in quality assurance is required.
• In-depth knowledge of quality management systems, standards, and methodologies (e.g., ISO 9001).
• Strong leadership and team management skills.
• Excellent problem-solving and analytical abilities.
• Effective communication and interpersonal skills.
• Proficient in using quality management software and tools.
• Certification in quality management (e.g., CQE, CQM) is preferred.
• Six Sigma certification is beneficial but not mandatory.

Job Description

• Track in-process quality-related issues and incidents in master issue list and periodically report on trends, insights, and closure status to BU management.
• Understand and classify issues into discipline such as quality, operational, design, etc.
• Host post-mortem discussion during each project closure to review issues and identify preventive action plan for each issue.
• Participate in manufacturing departments to track non-conformance reports filed during buy-off process and define preventive action plan.
• Champion long-term quality improvement efforts (new processes, structural changes, training, etc.) within the business unit to increase metrics such as first-pass yield and number of quality-related returns.
• Track and investigate quality-related returns and customer complaints with a view to long-term prevention.
• Coordinate First Article Inspection Process for new manufacturing processes or parts
• Lead continuous improvement initiatives to enhance product quality, reduce waste, and improve operational efficiency.
• Identify and implement process improvements based on lean manufacturing principles
• Supervise and mentor the quality assurance team, providing guidance and support to ensure their professional development.
• Foster a culture of quality and continuous improvement within the organization.
• Ensure the manufacturing facility maintains ISO certification.
• Coordinate and oversee all ISO-related activities, including internal and external audits.
• Act as the main point of contact for ISO certification bodies.
• Serve as the Management Representative (MR) for the QMS.
• Report to top management on the performance of the QMS and any need for improvements.
• Ensure the promotion of awareness of customer requirements throughout the organization.

Qualifications

• 5 - 8 years’ experience working in quality assurance is required.
• In-depth knowledge of quality management systems, standards, and methodologies (e.g., ISO 9001).
• Strong leadership and team management skills.
• Excellent problem-solving and analytical abilities.
• Effective communication and interpersonal skills.
• Proficient in using quality management software and tools.
• Certification in quality management (e.g., CQE, CQM) is preferred.
• Six Sigma certification is beneficial but not mandatory.

Assistant Manager / Manager, Quality Assurance

About CorDx:

CorDx is a multi-national biotech organization focused on pushing the limits of innovation and supply in global health. With over 2,000 employees across the world, serving millions of users in over 100 countries.

CorDx is transforming the global diagnostics industry with innovative R&D solutions, a vertically integrated supply chain, and manufacturing footprints in the United States and around the world.

With nearly two decades of IVD experience, CorDx is a leader in IVD research and development, manufacturing, and supply chain. Our proprietary line of rapid diagnostic products is recognized by families and medical professionals for reliability, affordability, and rapid results.

CorDx delivers rapid testing and point-of-care medical device solutions used in the detection of infectious disease such as COVID-19, pregnancy, drugs of abuse, biomarkers, and more. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.

Job Responsibilities

• Implement, manage and constantly improve the company’s quality management system, including but not limited to the IVD products and equipment;
• Regularly perform internal audits, compile audit reports, problem analysis reports, improvement proposals, and monitor the rectification plan and its implementation;
• Lead and Participate in the internal audits and management reviews of the company's quality system as key member of company's quality department;
• Manage the system and documents of company’s quality management system, including but not limited to the IVD products and equipment;
• Be specifically responsible for the IVD equipment quality management system;
• Statistical analysis of IVD equipment quality data, and draft reports and corrective and preventive measures;
• Update quality standards, laws and regulations and publish company quality policy;
• Establish collaborative and cooperative working relationship with key opinion leaders and the regulatory bodies;
• Collaborate with cross-functional teams to meet projects goals with overall organizational objectives.
• Any other ad-hoc duties or projects as required by the management team.

Qualifications:

• Quality system related training and internal auditor training;
• Familiar with ISO9000 & ISO13485 quality management system and certification work, experience with successful case(s) will be preferred;
• Familiar with GMP and medical device industry standards and specifications;
• Strong quality management system knowledge and capabilities;
• A bachelor's degree with 7 years of relevant experience, a master's degree with 3 years of relevant experience, or a doctorate degree with at least 1 year of relevant experience. Others are welcome to apply.
• Familiar with in vitro diagnostic products such as lateral flow immunoassay, PCR, Immunoassay etc;
• Familiar with IVD product development and commercialization life cycle;
• Systematical project management, good planning, execution and timely communication. Good presentation skills.
• Majoring in biology, medicine, laboratory science, immunology, pharmacy or quality engineering are preferred;
• Enthusiastic, proactive, and down-to-earth work attitude, strong communication & execution ability, results driven, and a team player;
• Meticulous and strong sense of responsibility; able to handle stress and tight schedule;

How to Apply:

• Please send a comprehensive resume, a cover letter (if applicable), along with your current and expected salary to foongying@cordx.com or click to submit here @ My careerfuture.
• We regret that only shortlisted candidates will be contacted

Responsibilities:

• To ensure supply chain processes comply with national regulatory compliance and meet international benchmarks and standards.
• Leads in addressing quality assurance issues in the production department
• Conduct walk by inspections and give real time feedback to team leaders and operators.
• Conduct regular internal audits, surveillance and inspections.
• Complete internal audits on time
• Update Quality manual
• Develop QA plans by conducting hazard analysis, identify Critical Control Points, implement preventive measures, establishing critical limits, monitor procedures, corrective actions and verification procedures.
• Provide advices on and propose in-house quality procedures, standards, and specifications to management.
• To assure consistency in product safety and quality by developing and enforcing Good Manufacturing Practice, validating existing processes, providing documentation and staff management.
• To work closely with Sales, Marketing, and Customer Service Departments to analyse customer complaints and feedbacks, and act as a catalyst for change and improvement in product quality to meet changes in existing customer’s requirements.
• Ensure ISO standards are implemented by all QC Executives (Food Technologist), team leaders and operators.
• To provide leadership and guidance, orientate, train, and guide QC / QA staff and other subordinates on their job.
• Work with Production and QC to establish SOP / WI for use in training staff, like new workers

Requirements:

• At least 3 years and above experience in a similar role in a food production company
• Mastery of FSSC 22000, ISO, HACCP, and Halal standards
• Experience in Food Safety regulatory auditing will be an added advantage
• Self-driven, self-discipline, good team worker
• Self-management (stress management, work organization, time management)
• Willingness and flexibility to work in special projects requiring his/her skills
• Able to communicate fluently in Mandarin and written Chinese

Qualification: Degree or Diploma in Machanical Engineering from a recognised university

Additional Qualification: Certified welding inspector CSWIP level 2 and ASNT Level-II NDE Technician cert. Conversant with API 620, API 650, API 653 standards inn addition to ASME, ASNT etc.

Nature of Work:

Able to work independently with the complete quality control aspects of storage tank and Process piping Construction including process inspection, report generation, client coordination, testing and inspection.

Able to make Project Quality Plans, Inspection & Test Plans, Work Instructions and SOPs for various erection and test activites in accordance with relevent standards and codes.

Review engineering drawings, preparing Inspection & Test plan, Quality manuals, attending meeting with client on design and technical clarifications etc.

Managing a team of Quality control personnel and coordination with NDE personnel for performing NDE examination at work sites.

1. Leadership and Management: Quality Manager requires strong leadership committed to quality improvement. Leaders set the vision, goals, and strategies for TQE implementation, allocate resources, and provide support and guidance to employees.
2. Quality Planning: This involves setting quality objectives, identifying customer requirements, establishing processes to meet those requirements, and developing plans to achieve continuous improvement.
3. Training and Education: Quality Manager emphasizes the importance of training and educating employees at all levels of the organization to ensure they understand quality concepts, tools, and techniques, and can contribute effectively to improvement efforts.
4. Quality Control: Monitoring and measuring processes and outputs to ensure they meet quality standards. This may involve statistical process control, inspections, audits, and other quality control techniques.
5. Quality Improvement: Identifying opportunities for improvement, analyzing root causes of problems, implementing corrective and preventive actions, and continuously striving to enhance processes and products/services.
6. Customer Focus: Understanding customer needs and expectations, gathering feedback, and using it to improve products/services and enhance customer satisfaction.
7. Supplier Management: Working closely with suppliers to ensure they meet quality standards and deliver high-quality inputs, materials, and components.
8. Employee Involvement and Empowerment: Encouraging and empowering employees to participate in quality improvement efforts, share their ideas and suggestions, and take ownership of quality-related activities.
9. Measurement and Analysis: Collecting and analyzing data to track performance, identify trends, measure progress toward quality objectives, and make data-driven decisions.
10. Continuous Improvement: Establishing a culture of continuous improvement where all employees are encouraged to seek opportunities for improvement, experiment with new ideas, and learn from successes and failures.
11. Communication and Collaboration: Facilitating open communication and collaboration across departments and levels of the organization to ensure alignment of quality goals and efforts.
12. Documentation and Documentation Control: Maintaining accurate records of quality-related activities, processes, and outcomes, and ensuring proper documentation control to prevent errors and ensure compliance with quality standards and regulations such as ISO 9001-2015.

KEY ACTIVITY

• This position is responsible for Implementing the quality audit and compliance monitoring system to assure the Civil Aviation Authority of Singapore (CAAS) Approved Maintenance Organization (AMO) processes and procedures are being followed, capable of delivering safe aviation products and in compliance with the SAR Part 145.
• Assume the position of Safety Manager and implement the safety management system for the AMO.
• Supervising and directing all personnel nominated to be certifying staff for the AMO.
• Liaising with CAAS and/or any certification bodies, e.g. ISO 9001, ASA, etc. on matters relating to the quality system and safety management system.

QUALIFICATIONS

• Aviation experience of no less than 5 years with at least 3 years in quality assurance / quality control experience in a managerial or supervisory capacity.
• Possess Polytechnic qualifications in Mechatronics/Mechanical/ Electrical/Aerospace or Quality Management or its equivalent. A degree in Engineering will be advantageous.
• Passed CAAS papers: Air Law (M10/L11/L12) and preferably in Human Factors.
• Completed a lead auditor course in quality management or its equivalent.
• Holding or has held a CAAS aircraft maintenance license or CAAS approved workshop certifying staff qualification is an advantage.
• Ability to read and write English.

ROLES AND RESPONSIBILITY

• Establishing and maintaining a compliance monitoring system to assure the CAAS approved maintenance organization (AMO) processes and procedures are being followed, capable of delivering safe aviation products and in compliance with the SAR Part-145.
• Planning and conducting independent audits on the AMO maintenance activities and the contracted service providers.
• Providing independent advice to the Accountable Manager relating to the implementation and maintenance of the safety management system.
• Administrating the quality feedback system to report on the performance of the quality system. safety management system and audit findings to the Accountable Manager.
• Assisting the Accountable Manager to develop improved methods and procedures for the performance of quality assurance and safety management functions.
• Assisting, supervising and directing all personnel nominated to be certifying staff for the AMO.
• Establishing and maintaining the requirements for initial and recurrent training for personnel involved in the maintenance and preventive maintenance of aviation products.
• Assessing and authorizing suitably qualified personnel to perform inspection functions for the AMO.
• Issuing SAR-145 certification authorizations to suitably qualified personnel to issue the certificates of release to service for the products or parts maintained by the AMO.
• Maintaining the AMO rosters and ensuring that changes in job personnel or job duties are reflected on the roster.
• Ensuring the training and qualification records of the AMO personnel are kept securely and orderly.
• Ensuring the maintenance organization exposition (MOE) and Safety Management System (SMS) manual are current and accurate, updating CAAS on all revisions status.
• Liaising with CAAS and/or any certification bodies, e.g. ISO 9001, ASA, etc. on matters relating to the quality system and safety management system.
• Reporting safety related occurrences that fall under the mandatory occurrence reporting criteria to the CAAS and conducting safety investigation as required.
• Conducting surveillance on the AMO facilities, procedures, and the availability of proper inspection records, reports, and forms used by the AMO are available to all inspection personnel.
• Ensuring procedures used in the procurement and receipt of aircraft parts are effective to detect "bogus" and "unapproved" parts from entering the parts system, and any such parts are detected before their use.
• Ensuring periodic checks are made on all inspection tools and the calibration of precision equipment used by the AMO including the current records of those inspections and tests are maintained.
• Determining all technical data on components overhauled or repaired by the AMO are kept current with latest revisions. This data includes manufacturer's overhaul manuals, service bulletins, part specifications, related CAAS approved data, and other technical data used by the AMO.
• Maintaining and keeping current a regulatory library including the applicable CAAS aviation regulations and airworthiness directives.
• Establishing and maintaining the capability listing of the aviation products in accordance with the CAAS approval ratings held by the AMO.
• Providing the necessary technical documents to the customers and storage of the AMO technical records.
• Performing safety management duties as required by the Accountable Manager

REPORTING LINE

This position reports directly to the Accountable Manager.

Role: Responsible for GMP-compliant quality control tests of cell products.

(Job title and salary commensurate with experience)

Job scope:

1. Performing quality control tests for clinical materials (cell therapy products) according to GMP standards.
2. Work with the Cell Manufacturing & quality control team.
3. Ensuring GMP compliance is maintained at all times.
4. Be accountable for the highest level of execution of regulatory strategies, and standards of quality compliance.

EXPERIENCE REQUIREMENTS

1. Experience in quality control tests of immune cell products, previous quality test experience of CAR-T/TCR-T/NK cell products is highly desired.
2. Experience in FDA IND filing.
3. Familiar with immune cell manufacturing, flow cytometry analysis; Cytokine measurement assays; qPCR assays; etc.
4. Self-motivated, good interpersonal skills.
5. Project management experiences.
6. Candidate who is bilingual (spoken) English-Chinese will have an advantage.

EDUCATIONAL REQUIREMENTS 

• Bachelor & more advanced degree in cell biology /biomedical sciences or in a similar medical technology related field.

* We regret that only shortlisted candidates will be notified.