Senior Quality Assurance Manager, Product Development

A*STAR RESEARCH ENTITIES; Singapore; On-site; SGD 80,000 - 110,000; Full time

Job summary

A leading MedTech organization in Singapore is seeking a Senior Quality Assurance Manager to oversee the Quality Management System and ensure compliance with global standards. The ideal candidate will have 5-7 years of experience in quality assurance in regulated environments and strong knowledge of ISO13485, FDA QSR, and EU MDR. Responsibilities include managing audits, collaborating with cross-functional teams, and driving continuous improvement initiatives. A postgraduate qualification or relevant certification is preferred.

Qualifications

• Minimum 5 to 7 years of experience in quality assurance in medical devices or regulated healthcare sectors.
• Proven track record in establishing and maintaining QMS in a regulated environment.
• Strong knowledge of ISO13485, FDA QSR, EU MDR, and risk management standards.

Responsibilities

• Implement, maintain and support the Quality Management System (QMS).
• Develop and maintain policies, SOPs, and documentation for QMS.
• Lead quality planning for projects and ensure risk management.
• Manage internal and supplier audits.
• Partner with cross-functional teams to integrate quality into product design.
• Identify opportunities for continuous improvement in quality assurance processes.

Skills

Quality Management System (QMS)

ISO13485

FDA QSR

EU MDR

Risk management

Stakeholder management

Analytical skills

Problem-solving

Education

Degree in Engineering, Biomedical Sciences, or related discipline

Postgraduate qualification or regulatory/QA certification (e.g. ASQ, RAC)

Job description

MedTech Catapult is a national initiative to accelerate the productisation and commercialisation of high-value MedTech products and to strengthen Singapore's MedTech innovation ecosystem. The in-house product engineering and development team provides end-to-end design & development and verification & validation capabilities. The Senior Quality Assurance Manager will play a critical role in ensuring that MedTech Catapult projects meet global quality and regulatory standards, ensuring compliance, risk management, and continuous improvement to enable successful translation and commercialisation of MedTech innovation. The Senior Quality Assurance Manager will report to the Lead of Product Development.

Job Responsibilities

• Implement, maintain and support the Quality Management System (QMS) to ensure compliance with ISO13485, FDA QSR, EU MDR, and other applicable standards.
• Develop and maintain policies, SOPs, and documentation to support MedTech Catapult?s QMS and product development, verification/validation, and regulatory submissions.
• Lead and support quality planning for MedTech projects, ensuring risk management, design controls, and validation activities are embedded throughout the development cycle.
• Assist in maintaining compliance with the ISO 13485 Quality Management System, including document control, corrective and prevention action (CAPA) using manual and electronic platforms.
• Manage internal quality audits, supplier audits, and external certification audits, and ensure timely closure of non-conformities.
• Partner with engineering, regulatory, project management and clinical affairs teams to ensure quality considerations are integrated into product design and testing.
• Implement and execute training programmes and associated awareness initiatives to build a strong quality culture across MedTech Catapult.
• Manage supplier quality assurance processes, including qualification, monitoring, and performance review of contract manufacturers and vendors.
• Identify opportunities for continuous improvement in quality assurance processes and systems.
• Support MedTech Catapult to interface with regulators, certification bodies, and industry partners on matters relating to quality assurance and compliance.

Requirements

• Degree in Engineering, Biomedical Sciences, or a related discipline; postgraduate qualification or regulatory/QA certification (e.g. ASQ, RAC) preferred.
• Minimum 5 to 7 years of experience in quality assurance in medical devices, life sciences, or regulated healthcare sectors.
• Strong knowledge of ISO13485, FDA QSR, EU MDR, risk management (ISO14971), and design controls.
• Proven track record in establishing and maintaining QMS in a regulated environment, preferably in FDA Class II and Class III medical devices.
• Familiarity with FDA Class II and III medical devices, including AI-based systems, connected health devices, or minimally invasive surgical tools will be an advantage.
• Demonstrated experience managing supplier quality and working with contract manufacturers.
• Strong stakeholder management skills, with the ability to work across cross-functional teams.
• Hands‑on experience with QMS/eQMS and familiarity with document management workflow
• Excellent analytical, problem‑solving, and decision‑making abilities.
• Strong written and verbal communication skills, with confidence in representing the organisation in audits and regulatory interactions.

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.