Total 21 Manager quality assurance job vacancies in d23 hillview dairy farm bukit panjang choa chu kang

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.

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

At Shangri-La Singapore we are a heart-warming family. We share something powerful – our genuine care and respect for others. Our strength lies beyond our harmonious surroundings and hideaway locations. It lies in our core values that guide us to treat each and every one with honour, as kin, as family. We strive to be the preferred employer by providing great benefits, tranquil and sincere working environment, work-life balance and effort recognitions.

Set in 15 acres of lush greenery just minutes from the vibrant Orchard Road shopping belt, the Shangri-La Hotel, Singapore is a tranquil, sophisticated urban retreat whether travelling for business or leisure. It features 792 luxurious guestrooms and suites across three distinct wings, which include unique family-themed rooms, supported by a host of dedicated family-focused amenities.

We are looking for a Manager, ESG and Quality Improvement to join our team!

The Manager, ESG (Environmental, Social, and Governance) and Quality Improvement, is responsible for overseeing the development, implementation, and continuous improvement of Quality Improvement initiatives aimed at advancing our Key Strategies to Achieve Excellence.

The role will focus on sustainability, social responsibility, governance, and operational excellence. This includes overseeing the five key areas: Environment, Supply Chain, Employees, Stakeholder Relations, and Health & Safety. Additionally, the role is responsible for promoting initiatives related to 'embrace' and/or sanctuary, ensuring clear communication, and fostering a thorough understanding and execution of CSR practices

The role combines a commitment to both environmental and social responsibility while focusing on enhancing the quality of hotel services and operations. The ideal candidate will be a proactive leader capable of managing ESG programs, driving sustainable practices, and leading quality improvement projects to enhance guest satisfaction and operational efficiency.

Quality Improvement

• Continuously encourages reporting and recording of defects from all sources daily.
• Ensures all guest defects are resolved prior to or after guest had departed the hotel.
• Statistical analysis of data and reduce the recurrence of trend defects.
• Identify specific key drivers of satisfaction for hotel and communication of results throughout the hotel. Partners with regional office to provide leaders with Operational Reports and analysis to meet/exceed goals.
• Facilitates core project teams, ensures utilization of quality tools and reports out/updates hotel leaders and regional office the status of the team Responsible for training new and existing colleagues on the utilization and benefits of QI initiatives for continuously improving systems and processes.

Environment:

• Supervise and support the hotel’s Environmental Management System (EMS) through ISO14001 certification
• Work with the engineering team to ensure targets for water, energy and Co2e are met
• Implement activities and policies that promote environmental awareness

Supply Chain:

• Work with the purchasing team to ensure the supplier code of conduct and green purchasing guidelines are upheld
• Develop partnerships with local and eco-friendly suppliers
• Communicate any pertaining CSR related information at yearly supplier forums

Employees:

• Develop a meaningful CSR employee volunteerism calendar of events to meet hotel targets
• Work with HR to ensure Shangri-La standards for staff wellbeing, hotel facilities and fair working practices are maintained
• Support the group wide policy to include 2% of permanent headcount of People with Disabilities (PWD’s)

Stakeholder Relations

• Conduct conducive dialogue and share good CSR practices with local communities, NGO’s, civil society, local government and businesses
• Ensure expertise from the hotel is used towards making a positives impact on the local community
• Where needed, register as member of local associations and attend meetings to leverage CSR locally

Health and Safety

• Supervise and support Occupational Health & Safety certification (ISO 45001)
• Support Fire Life Safety standards across the hotel
• Work with HR to develop targeted health activities for employees

About Foodsta Kitchens

Headquartered in Singapore, Foodsta Kitchens is a digital first restaurant company with operations in Singapore and India. Foodsta owns and operates 6 fast casual brands in Singapore – Bloom Cafe Pte Ltd (Formerly known as Artisan Boulangerie Co.(ABC), Alt. Pizza, Green Monster, Chi Ji and Fat Mario, Now Pizza. We believe that people are the foundation of our business are committed to providing a fun work environment and scope for rapid career development.

Reports To: Director

Key Responsibilities:

Audit and Compliance

Food Quality and Operational Audits:

• Develop and implement comprehensive audit programs to assess food quality, safety, and compliance with internal and external standards / regulations (e.g., SFA, HACCP).
• Conduct regular, detailed audits across multiple locations, focusing on health and safety, preparation processes, and final product presentation.
• Perform mystery shopper assessments and operational reviews, particularly targeting high-volume quick service restaurants (QSR) and fast-food environments, to ensure consistent adherence to quality standards. In addition, work with external agencies.
• Analyze audit findings to identify non-compliance issues and develop corrective and continuous action plans.
• Use feedback mechanisms to identify areas for improvement, ensuring continuous enhancement in both product and service quality.

Training and Development

Quality and Compliance Training:

• Design and implement robust training programs focusing on food safety, quality control, and regulatory compliance.
• Train kitchen and service staff on food science principles, emphasizing best practices in hygiene, safety protocols, and quality assurance.

Halal and SFA Compliance:

• Liaise with certification bodies to ensure compliance with regulations across all products and processes.
• Enforce strict adherence to halal standards, from ingredient sourcing to final food preparation.

Innovation

Menu Development:

• Work with the culinary, operations and marketing teams to design innovative menu items, focusing on market trends, customer preferences, and seasonal ingredients.
• Leverage food science and nutrition expertise to create balanced, appealing, and nutritionally sound offerings.
• Research and analyze competitor products, particularly in fast food and QSR sectors, to introduce unique, high-quality pizza and other menu items.
• Conduct extensive testing and refinement of recipes, ensuring they meet taste, quality, and nutritional standards before integration into the menu.

Continuous Improvement

Process Optimization:

• Identify inefficiencies in operations, particularly in high-volume QSR and fast-food settings, and implement process improvements.
• Utilize data analytics and customer insights to refine processes, enhance service delivery.

Qualifications & Experience

Education:

• Diploma in Culinary Arts, Food Science, Hospitality Management, or Business Administration.
• Certifications in food safety (e.g., HACCP, ISO 22000, WSQ Level 3) strongly preferred.

Experience:

• Minimum 5 years of experience in audit, food innovation, quality management, or product development, specifically within QSRs, fast food chains, or multi-location F&B environments.
• Proven track record in menu development, applying food science and nutritional principles to create appealing, health-conscious offerings.
• Experience leading cross-functional teams and implementing quality systems across multiple outlets.
• Knowledge of pizza workflow is a plus point.

Skills & Competencies:

• Strong creative thinking with a deep understanding of food science, nutrition, and culinary innovation.
• In-depth knowledge of quality management systems, food safety standards, and operational processes in fast food and QSR settings.
• Excellent communication and leadership skills to collaborate across teams and locations.
• Analytical and problem-solving abilities to translate data and customer feedback into actionable improvements.
• Bilingual proficiency in English and Mandarin is advantageous.

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 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.

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.

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.

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.

• 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.

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.

Quality and Supply Chain Manager

Job Description

Nuevocor is a pre-clinical stage biopharmaceutical company dedicated to developing genetic medicines to treat the underlying cause of genetic cardiomyopathies. Backed by an international syndicate of reputable venture capital firms, it will focus on advancing its pipeline of programs to clinical trials. It will also leverage its platform technology, underpinned by a deep understanding of cardiac mechanobiology, to discover and develop therapies for multiple cardiomyopathies.

Nuevocor’s Singapore site is seeking to hire a Quality Manager to join our Tech Ops department to support advancing our therapeutic candidates forward. Reporting to the Head of Tech Ops, you will play a key role in setting up, managing and maintaining our Quality Management System and processes in compliance with relevant standards and regulatory requirements. You will be part of a dynamic and fast-paced biotech working environment.

Responsibilities

· Implement, manage and maintain a compliant GxP Quality Management System, encompassing the aspects of Quality Risk Management, CAPA, Deviations, Change Control, Quality Documentation.

· Conduct internal and external audits, including at sub-contractor facilities and processes.

· Provide on-site support at CDMOs for manufacturing production.

· Manage supply chain of materials across sites of CDMOs, CROs and clinical trial sites.

· Prepare Quality documentation and agreements.

· Review GxP protocols, reports and Standard Operating Procedures to ensure compliance.

· Develop and deploy the GxP quality assurance strategy as approved by senior management.

· Reports all critical and relevant quality and compliance issues to management.

· Ensures quality assurance expertise is available and effective for GxP operations.

· Provide Quality Assurance review and disposition of GxP products, as appropriate.

· Acting as a point of contact with regulatory authorities.

· Support the development and harmonization of quality standards and processes.

· Maintain good relationships with regulatory agencies.

· Ensure that all personnel training, investigations, actions, CAPAs are completed on time.

· Assists in the development and maintenance of training program.

· Lead and assist in the development of SOP and procedures to support GxP functions.

Requirements

· Scientific degree in Pharmaceutical Sciences or related fields.

· 5-10 years experience in GxP particularly GCP and GMP areas and other regulations applicable in the Pharmaceutical Industry.

· Experience with supply chain and shipping, preferably with biologics materials.

· Knowledge of drug development regulations and implementing GxP in Gene Therapies

· Actively able to manage multiple projects to meet timelines, while maintaining compliance.

· Ability to work in teams with diverse cultural and professional backgrounds

· High standards in documentation and record keeping.

· Strong interpersonal and organizational skills

· Strong collaboration and team working skills

· Excellent writing and verbal communication skills

· Excellent problem solving ability

· Ability to multitask

· Possess a mindset of no job too big or too small

Nuevocor is an equal opportunity and equal benefits employer. All qualified applicants will receive consideration for employment. Position is commensurate with experience.

Interested candidates, please submit a CV and cover letter to tinyurl.com/nuevocorcareer

This role will Ensure products manufactured by contract manufacturer meet all defined specifications and are developed and manufactured in compliance with all applicable quality system requirements and provide leadership to work with different Medtronic entities and set up the strong relationship to support the implementation of Quality Systems for the new entity in implementing China localization strategy.

Primary Responsibilities

• Set up the Quality Systems to it meets Singapore, China and requirement countries requirement.
• Establishes quality programs and initiatives to ensure products and assemblies are developed and manufactured per applicable requirements.
• Establish strong supplier control and Quality oversight over suppliers and Medtronic entities.
• Driving continual and preventive improvement of quality management systems in supporting the conformity of process and product quality.
• Supports and develops systems for the identification, analysis, correction, and prevention of quality issues.
• Contributes quality expertise to product development and manufacturing transfers including working closely with suppliers to implement robust manufacturing processes and Quality oversight.
• Oversees and lead key quality systems processes to ensure its effectiveness which includes Design Control, Supplier Controls, Quality Planning, Document Controls, Training, Audits, Change Controls, Nonconformance CAPA, Manage External Requirement, etc.
• Leads the site audit readiness and manages, conducts and coordinates external (Singapore, China, ISO, etc.) audits.
• Take preventive actions to improve the compliance and effectiveness of Quality Management Systems by proactive learning from other sites and best practices from the industry.
• Provides QA support, participate and collaborate with Operating Units improvement program
• Works with local management team members in developing long and short-term quality goals and strategies.
• CAPA board memberParticipate in CAPA and board meetings to review the trending of all input sources and determine if any further action is needed
  Perform review on the CAPA investigation, action plan and effectiveness to determine if CAPA process requirement are fulfilled.
• Represents the new entities to collaborate with peers across all Operating Units for global quality initiatives and works closely with peers on similar quality concerns between Medtronic sites

Qualifications - External

Must Haves

• Bachelors Degree required
• Minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience

About Johnson & Johnson

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.

Johnson and Johnson Network Operations Team is seeking an innovative Manager - Network Performance Assurance!

Major Duties and Responsibilities :

This is a highly technical role that is part of a global team to troubleshoot and resolve sophisticated and chronic network performance/operational issues. The Performance Assurance Manager is a SME in all major network technologies such as Switching/Routing, WAN, WLAN, Firewalls, Load Balancers, Cloud Exchange/CoLo, Cloud-based network services, and SDN. This position will partner with peer technology domain teams (Desktop, Server, Application, Cloud, etc.) when vital to identify performance issues and drive the resolution. One of the primary goals of this position is to focus on improving global network reliability and resiliency by proactive remediation of potential issues that could cause future business impact. Additionally, this role will ensure that proactive corrective, and preventative activities resulting from Problem Management are implemented.

The Manager- Network Performance Assurance will be accountable for the assessment of network site health reports that focus on network performance, configuration review and identifying continuous improvement, single points of failure and any required remediation.

Additionally, the role will solicit and receive feedback from business partners regarding network performance with the goal of growing the reliability and stability of the global network. This role will also serve as internal consultant for operational projects, partner with the Global Network Engineering team to standardize configuration changes and automation based on findings and recommendations. The position will engage OEM’s for information regarding bugs, patches, software upgrades, and configuration changes.

Qualifications:

• Bachelor’s degree in STEM or Computer Networking or Data Communications ( Desired)
• Possess an advanced network certification such as CCNP / CCDP or higher (Desired)
• 10+ years of large / enterprise Network Operations expertise and experience (Required)
• 5+ Years of experience in Next Gen network technologies like Cloud Networking, SD-WAN and Network Virtualization (Desired)
• 3+ Years of experience in Itential, Ansible or Python, Automation / scripting (Desired)
• 3+ years of experience in tools integration and single plane of glass observability (Desired)

Knowledge, Skills and Abilities:

• Strong Network Troubleshooting & Operations experience in complex Network environments (Required)
• Solid understanding in these technologies: routing/switching, WAN technologies, EIRGP/BGP, VPN, SASE, Zero-trust, SDN (SDA, SDWAN), Cloud connectivity, Cloud-based Networking technology, WLAN Technologies (Required)
• Broad technical knowledge and experience with converged infrastructure, Switching/Routing in a large and complex network, DHCP, DNS, IP, IP management tools, network management applications, advanced WAN routing, WAN/LAN/Wireless LAN topologies, MPLS, EIGRP/BGP, Load Balancers, Firewalls etc. (Required)
• Knowledge of High availability / resiliency engineering (Required)
• Confirmed vendor management experience (Required)
• Solid experience using network management and troubleshooting tools include packet analysis (Required)
• Demonstrable experience leading virtual teams supporting a complex network environment
• Excellent written and oral communication skills (Required)
• Proven analytical, evaluative and problem-solving abilities; data-driven. (Required)
• Working knowledge on BI tools such as Power BI and Tableau. (Desired)
• Ability to optimally prioritize and execute in a fast paced environment (Required)
• Outstanding customer service orientation (Required)
• Extensive experience working in a team-oriented, collaborative environment (Required)
• Scripting in Itential, Ansible or Python, Automation / scripting, Virtual Networking (NSX), AWS, AZURE and Equinix Cloud Exchange ( Desired )

What’s in it for you…?

“Caring for the world, one person at a time…”

As an employee, we consider you as our most valuable asset. We take your career seriously. As part of a global team in an innovative environment, your development is key and our day-to-day responsibility. Through e-university, on job training, various projects, and programs, we ensure your personal growth. Our benefits make sure we care for you and your family now and in the future! We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, depending on location and subject to local legislation, candidates offered employment may be required to show proof of COVID-19 vaccination or, in certain countries, secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work. If you are invited to interview for the position, your recruiter will advise on the vaccine requirement status in your geographic location.

#JNJTech

Are you looking to lead the growth of ESG and sustainability services in an innovative, digitally enabled, purpose driven business? Are you motivated to support customers and drive positive impact to their business and the society to achieve success through a range of assessment, advisory and analytics solutions?

We’re recruiting for a growth focussed Sustainability Manager/Lead with proven seller-doer consulting experience in the domain of ESG and Sustainability to join our Global Sustainability, Assessment & Assurance team to help us achieve our vision and goals.

This is an exciting opportunity to achieve growth as a seller doer, lead the delivery of projects, ensure service excellence for clients and play an important role in development of others within the team.

We help clients implement, improve and demonstrate their commitment and progress towards authentic sustainability goals. Our portfolio of assurance and consulting projects include non-financial Report Assurance, ESG strategy, responsible sourcing, climate change related services including LCA, Green Finance and human rights. You will get the opportunity to win, lead and develop our work on a wide range of sustainability services.

When doing this, you will get the opportunity to engage with many of the region’s leading companies and brands across a wide range of sectors and to leverage a suite of services and digital technologies to scope, sell and deliver innovative solutions.

Main Responsibilities

• Proactively seek to identify customer needs, develop tailored solutions and sell these to new and existing clients.
• Leading and communicating effectively with your project teams and clients.
• Introducing services from your own/existing discipline(s) to new clients and new services to existing clients.
• Carrying our independent assurance audits for clients Sustainability/Integrated reports (IR)/ESG reports based on various reporting frameworks like GRI, IR Framework, SASB, TCFD etc.
• Involvement in independent assessment / verification of client’s sustainability indicators involving environment (Scope 1, 2 and Scope 3 emissions), social and governance indicators.
• Involvement in the execution of ESG Assurance projects.
• Involvement in review and assessment of client’s net Zero Targets or Science based Targets.
• Involvement in materiality assessments, impact assessments, review of stakeholder engagements
• Support organizations in implementing TCFD recommendations, assessing climate-related risks and opportunities, and supporting them in preparing high-quality disclosures to enhance transparency and enable informed decision-making by stakeholders.

Position Qualifications:

• University Degree in Engineering / Environmental science or Sustainability studies.
• Additional qualifications relevant to sustainability subject areas from GRI, SASB, BRSR, ISO 14064 etc. will be an advantage.
• At least 7-10 years of proven track record in delivering ESG & Sustainability services.
• Strong problem solving and data analysis skills, data interpretation and first principal problem-solving approach.
• Proven track record of leading & delivering of Sustainability services as a trusted advisor and thought leader in their domain of ESG / sustainability.
• Proven project and/or team leader, delivering service excellence.
• Able to provide sufficient guidance, support and feedback on performance of team members.
• Excellent and effective communication and written skills
• Collaborate well with others; share knowledge, experience, and information; support others in the pursuit of team goals.
• Ability to interact and cooperate across cultures.
• Willingness to travel and work around Singapore and on occasions overseas.

Knowledge and Skills:

We are looking for senior and dynamic candidates who:

• Has a good understanding of ESG reporting frameworks, such as GRI, CDP, IR Framework.
• Has a good understanding of GHG Protocols, ISO 14064 and SBTi.
• Has relevant experience in ESG Assurance on various ESG disclosures in line with ISAE 3000 (revised) and / AA1000 assurance standard.
• Has a good knowledge of existing and evolving ESG concepts and practices across sectors/geographies including Life Cycle thinking.
• Has a deep understanding of the ESG market in the region.
• Is good in leading the project deliveries - delivering on-time, on-budget and achieving high levels of internal and external customer satisfaction.
• Maintains flexibility in work hours and work independently with minimal supervision.