About the role
Senior Design Quality Assurance Manager at MedTech Catapult responsible for ensuring projects meet global quality and regulatory standards, driving compliance, risk management, and continuous improvement to enable successful commercialisation of MedTech innovations.
ResearchOnsiteMedTech Catapult
Key Responsibilities
- Contribute to new and existing product development projects and sustaining projects for electromechanical systems, connected devices, and medical devices.
- Develop, establish, and maintain quality-engineering methodologies, systems, and practices meeting MC QMS, customer, and regulatory requirements.
- Provide quality and compliance inputs to project teams for decisions and deliverables throughout the development life cycle (design change analysis, design inputs/outputs, test method development, design reviews, verification/validation, usability testing, process validation, labelling).
- Lead risk management processes for new products with cross-functional teams, including risk management plans, reports, risk/benefit analysis, hazard analysis, dFMEA, pFMEA.
- Lead projects as design quality subject matter expert and review hardware/electrical/software system architectures to identify failure modes and risk control opportunities.
- Support MC QMS to ensure compliance with ISO 13485, FDA QSR, EU MDR, and other applicable standards.
Requirements
- Degree in Electrical Engineering, Biomedical Sciences, or 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 ISO 13485, FDA QSR, EU MDR, risk management (ISO 14971), IEC 60601, IEC 62304 and design controls.
- Applied knowledge in 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.