Apsida Life Science is currently partnered with an innovative, up-and-coming cardiovascular MedTech organisation who are supported by recent investment and clinical momentum, including pivotal trial progression. The team are seeking a Design Quality Engineer to join, who will play an important role between QARA and R&D.
Responsibilities:
- Provide design quality support across the full medical device lifecycle, including development, design changes, and post-market activities.
- Collaborate closely with R&D teams to maintain and update risk management documentation.
- Support activities related to Risk Management Plans, Hazard Analyses, dFMEAs, and Risk Management Reports.
- Contribute to quality feedback processes including Complaints, Non-Conformances (NCs), and CAPAs.
- Support continuous improvement initiatives across design control and change management processes.
- Assist in developing and maintaining traceability systems and quality tools to ensure compliance and efficiency.
Qualifications:
- Minimum of 5 years' experience in a medical device manufacturer or manufacturing subcontractor.
- MUST have technical expertise and experience in hardware and software design and development.
- Experience in EU CE certification processes and/or US clearance processes.
- Experience in coordinating activities involving cross-functional teams.
- Mindset oriented towards problem-solving, synthesis, continuous improvement, and cross-functional project management.
If you are interested in learning more, please contact Geneva Jones at Apsida Life Science: [email protected].
Apsida Life Science is a specialist recruitment business based in London (UK), Redhill (UK), Boston (USA) & Pretoria (South Africa) that is dedicated to delivering the best talent to the Life Science industry. We believe there is a gap in the market for a cost effective, high quality and trusted recruitment service that puts the candidate journey at the heart of the recruitment process.