Design QA Lead - Cardiovascular

Our client is an innovative cardiovascular medical device company developing advanced Class III implantable technologies. As they continue to develop their technology, they are seeking an experienced Lead of Quality Assurance - Design & Development to ensure products meet engineering, quality and regulatory requirements throughout the full design and development lifecycle through to design transfer.

The role

• Leading Quality Assurance activities across the design and development lifecycle.
• Ensuring Design & Development processes comply with the Quality Management System and applicable medical device regulations.
• Working closely with R&D, Regulatory Affairs, Engineering, Manufacturing and other cross-functional teams.
• Leading and participating in design reviews and reviewing/approving design inputs and outputs.
• Supporting Design Verification & Validation strategies, protocols, reports, test methods and sampling strategies.
• Supporting risk management activities including risk analysis and FMEA.
• Managing design changes, including impact assessments, verification/validation activities and documentation traceability.
• Supporting usability engineering activities and ensuring applicable standards are incorporated into development.
• Ensuring the completeness and maintenance of the Design History File / Medical Device File and traceability documentation.
• Supporting Design Transfer from R&D into manufacturing.
• Providing Quality and technical expertise for customer complaints, CAPAs, post-market activities and quality investigations.
• Supporting Regulatory Affairs with documentation required for EU and FDA regulatory submissions.

Required experience

• Minimum 5 years' experience within the medical device industry, specifically in the Design & Development of Class III implantable medical devices.
• Strong experience with Design Control, Design Assurance and Quality Assurance within product development.
• Degree in Engineering or a scientific discipline, ideally Mechanical or Electrical Engineering.
• Strong knowledge of ISO 13485, ISO 14971, EU MDR 2017/745 and FDA QMSR / 21 CFR Part 820.
• Knowledge of relevant technical standards including IEC 62304, IEC 62366-1, IEC 60601-1 and ISO 11607.
• Experience with Design Verification & Validation, risk management, FMEA and design transfer.
• Experience working within an ISO 13485 regulated environment.
• Strong cross-functional experience working closely with R&D and Regulatory teams.
• Professional working proficiency in English (B2 level or above).

As a Recruitment Consultant at Aspire Life Sciences, Taylor Lyons specialises in technical and executive hiring across Medical Devices, Neurotechnology, AI, and DeepTech, partnering with innovative organisations across Europe, North America and Asia.