Quality Engineer
Medical Devices | Cambridge | Hybrid
Salary expected to be in the region of £50,000. The business recognises that candidates with significant Design Quality and Medical Device experience may command a higher salary and is open to discussion for the right individual.
I’m supporting an innovative medical device company that is looking to appoint a Quality Engineer to join its growing Quality team in Cambridge.
This is a broad Quality Engineering position offering exposure across design quality, supplier quality, auditing, risk management and continuous improvement activities, supporting both new product development and existing products.
Working closely with Engineering, Operations and Supply Chain teams, you’ll play a key role in ensuring products and processes remain compliant while supporting the ongoing development of complex medical technologies.
Key responsibilities
• Work with project teams to ensure verification, validation and review activities are robust and consistent
• Support Design Control activities throughout the product lifecycle
• Review and approve verification documentation, protocols and records
• Support design changes and product improvement initiatives
• Conduct supplier audits and support supplier quality management activities
• Support CAPA, NCR and root cause investigations
• Drive continuous improvement activities across quality processes
• Support compliance with ISO 13485, MDR, MDSAP and wider regulatory requirements
• Coach and support colleagues in the application of quality processes and procedures
• Maintain supplier quality documentation and approved supplier records
What we’re looking for
We’re interested in speaking with Quality Engineers who have experience within medical devices.
You may currently be working as a:
• Quality Engineer
• Design Quality Engineer
• Supplier Quality Engineer
• QA Specialist
• Quality Assurance Engineer
• Product Quality Engineer
Experience with a good mix of the following:
• ISO 13485
• IEC 60601
• Design Controls
• Medical Device product development
• Supplier auditing
• CAPA and NCR management
• Risk management
• Verification and validation activities
• MDR and MDSAP
Why apply?
This is an opportunity to join a company developing innovative healthcare technologies where quality is viewed as a business partner rather than simply a compliance function.
You’ll gain exposure across product development, supplier quality, auditing, risk management and continuous improvement, working closely with multidisciplinary teams in a highly regulated environment.
The role is expected to be based in the Cambridge office 3 days per week initially to support onboarding, collaboration and integration with the wider team. Greater flexibility may be available over time once established in the role.
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