Total 30 Manager quality assurance job vacancies in d19 serangoon garden hougang sengkang punggol

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

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.

Job Summary:

• Industry: Healthcare
• Working location: Kent Ridge

Job Responsibilities:

• Leads quality improvement initiatives and spearheads innovation projects, identifying areas for enhancement and implementing best practices.
• Assists in managing the day-to-day operations of the department, ensuring high standards of patient care and staff performance
• Analyzes data and prepares reports on quality metrics and innovation outcomes.
• Conducts training on quality improvement, new technologies, and innovative care practices, including facilitating quality improvement workshops.
• Ensures compliance with healthcare regulations and organizational policies. Supports Nursing in compliance to audits’ standards.
• Participates in interdepartmental meetings and committees to represent the Nursing Departments’ quality and innovation interests.
• Supports the department in managing administrative support and coordination with external parties for innovative projects and research grants.
• Establishes and maintains relationships with funding agencies, potential partners, and other stakeholders in the healthcare innovation ecosystem.
• Facilitate, coordinate and support Nursing Leadership with the department's annual work plan.
• Consolidates, reviews, and analyses periodic and ad-hoc statistical and management reports
• Undertakes any other tasks assigned.

Job Requirements:

• Bachelor’s Degree in Business/Engineering/Industrial Design/Healthcare from a recognized institution.
• Possess knowledge of quality improvement methodologies and innovation processes in healthcare.
• Strong understanding of AI and robotics applications in healthcare, or willingness to learn.
• Proficient in Microsoft Office, in particular Word, Excel and PowerPoint.
• At least two years of experience in facilitating workshops and conducting training.
• Familiarity with data analysis and statistical tools
• Knowledge of lean management principles and Six Sigma methodologies.

By submitting any application or résumé to us, you will be deemed to have agreed and consented to us disclosing your personal information to prospective employers for their consideration.

We regret that only short-listed candidates will be notified.

Registration No: R24123448 / EA Licence No: 12C6253

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.

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.

Job Summary:

• Industry: Healthcare
• Employment type: Permanent, full-time
• Working location: Kent Ridge

Job Responsibilities:

• Coordinate and support clinical quality and safety programmes within the organisation.
• Play an active role in identifying, coordinating and participating with relevant departments in developing quality models, standards development, design and implementation of audits and risk management activities.
• Ensure accurate data collation and compilation for various clinical quality activities including clinical performance indicators.
• Provide support to QA and Clinical Services committees and continuously seek opportunities to improve work processes and highlight areas for improvement.
• Manage incidents and serious reportable events and conduct root cause analysis.
• Demonstrate management skills necessary to work effectively with internal and external stakeholders/partners across the system and work with teams across the hospital and institutions.
• Facilitate presentation of improvement efforts and ongoing measures of clinical processes to management to enable an effective learning environment.

Job Requirements:

• Possess a bachelor's degree from a recognized institution
• At least 3 to 5 years of relevant working experience in healthcare. Working experience in medical affairs and clinical governance is preferred.
• Excellent data analysis, communication, writing and problem-solving skills
• Exceptional interpersonal and people management skills
• Positive, motivated and able to perform under pressure

By submitting any application or résumé to us, you will be deemed to have agreed and consented to us disclosing your personal information to prospective employers for their consideration.

We regret that only short-listed candidates will be notified.

Registration No: R24123448 / EA Licence No: 12C6253

• 5 days, Kallang, Manufacturing
• $6800 - $7200,AWS, variable performance bonus
• Good leadership skills

Job Responsibilities

• Lead and manage a team of quality engineers, technicians and line supervisors by providing necessary coaching and support on daily quality control activities as well as professional growth development in the department.
• Develop and implement quality assurance policies and procedures specific to products
• Establish quality control checkpoints at various stages of the production process to identify defects and non-conformities
• Conduct regular inspections and audits to ensure compliance with industry standards and customer specifications.
• Investigate root causes of quality issues and implement corrective and preventive actions.
• Work closely with production teams to address quality concerns in real-time and prevent reoccurrence on products with quality issues.
• Collaborate with the purchasing/sourcing team to liaise with suppliers to ensure the quality of raw materials and components used in assembly processes.
• Develop and maintain quality metrics and performance indicators to track and report on quality objectives.
• Train and mentor quality assurance staff to ensure competency and adherence to quality standards.
• Stay up-to-date with advancements in quality assurance techniques, regulations, and industry best practices.
• Drive a culture of quality excellence and continuous improvement throughout the company.
• Perform all other related duties as assigned by Plant Manager or General Manager

Job Requirements:-

• Bachelor’s degree in quality management, Industrial Engineering or preferably in Electrical & Electronic, Industrial, or Manufacturing Engineering.
• At least 8-10 years of experience in Quality Control manufacturing with at least 5 years in leadership roles with a track record of success in optimizing production processes and leading teams.
• In-depth knowledge of quality management systems (ISO 9001) and regulatory requirements (RoHS, REACH, etc.).
• Experience in root cause analysis, failure mode and effects analysis (FMEA), and statistical process control (SPC).
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across different levels of the organization.
• Able to perform in a fast-paced environment and meet deadlines
• Able to work well under pressure and handle emergency and stressful situations
• Positive mindset and Can Do Attitude
• Strong decision-making and people management skills

Interested applicants, please send your resume to [email protected]

You will be part of the Quality Service Department to handle appeals, feedback and enquiries related to public health issues. It is a fast-paced environment that would require the ability to manage multiple priorities at the same time.

You will be responsible for the following:

• Draft and/or vet reports and replies for feedback, appeals and enquiries to ensure that they comply with standard operating procedures and service standards;
• Handle service-related matters pertaining to the Public Health pillar;
• Handle difficult customers and effect service recovery where necessary;
• Track and analyse the volume, nature and trend of feedback and appeals received;
• Propose corrective actions, changes and improvements to processes so as to improve customer service and satisfaction

Requirements:

• Keen interest in environmental public health
• Excellent communication and interpersonal skills
• Excellent writing skills
• Strong leadership skills and a good team player
• Proficient in Microsoft Office applications

As part of the shortlisting process for this role, you may be required to complete a medical declaration and/or undergo further assessment.

https://sggovterp.wd102.myworkdayjobs.com/PublicServiceCareers/job/NEA-HBD-HUB/Assistant-Manager-Manager--Quality-Service-Department-_JR-10000031241

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

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.

• Responsible for overall Quality Engineering strategy development and providing oversight and control for quality engineering functions at Small Ag & turf Asia Manufacturing factories.
• Responsible for setting quality engineering goals for the Small Ag & turf Manufacturing Asia.
• Directs and controls new product introduction process from quality engineering perspective at Small Ag & turf Asia Manufacturing factories.
• Reviews qualify performance for the units on regular frequency.
• Guides Small Ag & Turf Asia factories to develop and implement ISO standard processes in alignment with internal Quality and Production System requirements.
• Communicates with Product Support and Marketing organizations to understand the customer sentiments.

Overview

You will oversee the Quality Service Management (QSM) function of the organisation and ensure its efficient running and operations. You will be working closely with the Director of Operations to seek to achieve a high standard in service quality for the organisation through continuously uplifting service standards on the ground.

Responsibilities

• Drive service in line with organizational goals.
• Develop, monitor and review the organisational service framework.
• Build and maintain a culture that energizes and recognizes service professionals, and foster a culture of learning, improvement and innovation to deliver quality service.
• Identify organizational service gaps, and develop interventions and curate training to address the gaps.
• Plan organization-wide service quality initiatives and events to continually improve service standards.
• Develop organizational-wide service indicators for compliance.
• Work with stakeholders to improve organizational standings at national level surveys and accolades.
• Oversee the management of feedback, complaints, compliments and appeals. This includes working with heads of departments in investigations and facilitating family conferences and replies.
• Work with internal and external partners to execute special projects and advise in the area of service experience and customer journey.

Requirements

• Preferably degree, preferably in Service, Hospitality and/or Healthcare-related disciplines.
• Preferably 7 years of relevant experience in Quality Service in a healthcare setting.
• Strong knowledge and experience in customer relations management and quality service management.

By submitting any application or resume to us, you will be deemed to have agreed and consented to us disclosing your personal information to prospective employers for their consideration.

We regret to inform that only short-listed applicants will be notified.

Ailing

Dynamic Human Capital

Registration number R23114618 | EA Licence No: 12C6253

Careers that Change Lives

We are a learning culture. An inventive and collaborative group. We are dedicated to making sure that every patient gets the best product — when they need it. We have strong ties to our local communities. Our vibrant employee communities respect and value individual experience and perspective as we aim to improve lives and the access to healthcare.

A Day in the Life

• Leads the QA function to ensure quality system development and compliance with FDA's Quality System Regulation, 13485, MDD / EU MDR, and other quality requirements.
• Provides oversight for the development and maintenance of quality programs, systems, processes and procedures that ensure compliance with policies and that the performance and quality of services conform to established internal and external standards and guidelines.
• Provides expertise and guidance in interpreting policies, regulatory and/or governmental regulations, and internal regulations to assure compliance.
• Provides guidance and coaching to all direct reports, includes establishing individual performance & development objectives and plan
• Leads the strategic planning the functional team in driving continual improvement and effectiveness of Quality Operations and Quality Systems.
• Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured in accord with applicable requirements.
• Leads and/or supports initiatives at Medtronic Singapore and across sites to ensure effective quality reporting, quality systems and quality improvement efforts and Customer-Focused Quality; supervise the Quality System implementation. Supports the implementation of engineering projects, including design transfers and provide management oversight in establishing the quality system requirement at other facilities and Medtronic projects.
• Act as the CAPA board chair to ensure effective CAPA process and drive the development of systems and processes for the identification, analysis, correction, and prevention of quality issues.
• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits.
• Works with Singapore and platform leadership team members in developing long and short-term business goals and strategies.
• Represents Singapore on OU/ enterprise Quality Leaders team meeting, collaborate with peers across all sites and Operating Units for global quality initiatives and works closely with peers on similar quality concerns between MDT sites.

Qualifications

Must Have

• Requires a Bachelor’s degree minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years prior relevant experience.

Your Profile

• Minimum of 5 to 7 years management expertise in the Pharmaceutical, Medical Devices or any highly regulated manufacturing industry.
• Overall operational and financial acumen, Business and Project Management skills and experience a plus.
• Familiar with Quality System requirement and knowledge of Quality System Regulations and ISO.
• Broad management knowledge to lead a team and have a prior experience in manufacturing environment and Quality function.

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.