Job Summary

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 Design Quality Assurance Manager will report to the Lead of Product Development.

Job Responsibilities

• The Senior Design Quality Assurance Engineer will contribute to new and existing product development projects and sustaining projects for electromechanical systems, connected devices and medical devices. Furthermore, they will develop, establish, and maintain quality-engineering methodologies, systems, and practices which meet MC QMS, customer, and regulatory requirements.
• Support and provide quality and compliance inputs to project teams for project decisions and deliverables throughout the development life cycle (i.e. Design Change Analysis; Design Inputs, Design Outputs; Test Method Development and Validation; Design Reviews; Design Verification and Validation; Usability Testing; Process Validation; and Labelling).
• Risk Management processes for new products with key inputs from cross-functional product engineering and development teams (i.e. Risk Management Plan, Risk Management Report, Risk/Benefit Analysis, Hazards Analysis, dFMEA, pFMEA, etc.)
• Lead projects as design quality subject matter expert and work with Product Engineers to review Hardware/Electrical/Software systems architecture(s) and identify possible failure modes/risk control opportunities for medical devices and electromechanical systems
• Support MC Quality Management System (QMS) to ensure compliance with ISO13485, FDA QSR, EU MDR, and other applicable standards.
• Develop and maintain policies, SOPs, and documentation as necessary to support MedTech Catapult’s QMS and product development, verification/validation, and regulatory submissions.
• Assist in maintaining compliance with the ISO 13485 Quality Management System, including document control, corrective and preventive action (CAPA) using manual and electronic platforms.
• Support internal quality audits, supplier audits, and external certification audits, and ensure timely closure of non-conformities.
• Partner with engineering, regulatory, project management and clinical innovation teams to ensure quality considerations are integrated into product design and testing.
• Support any 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.
• Manage MC project supplier and vendors in compliance with required compliance
• 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 Electrical 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), IEC 60601, IEC 62304 and design controls.
• Applied knowledge in the verification and validation of medical devices, including hardware, software, firmware, and systems of systems interdependencies
• 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.