About the role
AI summarisedThe Senior Design Quality Assurance Manager ensures MedTech Catapult projects comply with global regulatory standards, overseeing risk management and quality management systems for electromechanical and medical devices.
ResearchOnsiteMedTech Catapult
Key Responsibilities
- Support and provide quality and compliance inputs for project decisions throughout the development life cycle including Design Inputs, Outputs, and V&V
- Lead risk management processes for new products including Hazards Analysis, dFMEA, pFMEA, and Risk/Benefit Analysis
- Review Hardware, Electrical, and Software systems architectures to identify failure modes and risk control opportunities
- Maintain MC Quality Management System compliance with ISO 13485, FDA QSR, EU MDR, and other applicable standards
- Develop and maintain policies, SOPs, and documentation supporting product development and regulatory submissions
- Partner with engineering, regulatory, and clinical teams to integrate quality considerations into product design and testing
- Identify opportunities for continuous improvement in quality assurance processes and systems
Requirements
- Degree in Electrical Engineering, Biomedical Sciences, or a related discipline
- Minimum 5 to 7 years of experience in quality assurance in medical devices or life sciences
- Strong knowledge of ISO 13485, FDA QSR, EU MDR, ISO 14971, IEC 60601, and IEC 62304
- Applied knowledge in the verification and validation of medical device hardware, software, and firmware
- Proven track record in establishing and maintaining QMS in a regulated environment for FDA Class II and Class III devices
- Hands-on experience with QMS/eQMS platforms and document management workflows
- Experience managing supplier quality and working with contract manufacturers
- Excellent analytical, problem-solving, and cross-functional stakeholder management abilities
- Strong communication skills with confidence representing the organization in audits and regulatory interactions