Lead Design Quality Engineer - Medical Devices
Hybrid Role | 2 Weeks On-Site in Falmouth, Cornwall / 2 Weeks Remote
A rare opportunity has opened for an experienced Lead Design Quality Engineer to join a global healthcare organisation developing complex, highly regulated medical devices that directly impact patient outcomes worldwide.
This role offers a highly attractive hybrid working model, two weeks working on-site in beautiful Falmouth, Cornwall followed by two weeks working remotely from home.
The OpportunityYou will work closely with R&D, manufacturing, and supplier partners, shaping quality strategy across design controls, risk management, verification & validation, and supplier quality.
Key ResponsibilitiesDesign Quality Leadership*Act as the Quality representative within product and process development teams

*Lead design control activities including design reviews, verification, validation, specifications, and documentation

*Provide technical guidance on quality engineering methodologies

Risk Management*Lead risk management activities across product development

*Drive FMEA execution and risk mitigation strategies

*Partner with design teams to proactively manage product and process risks

Verification & Validation*Support development of master test plans, traceability matrices, and validation strategies

*Review test protocols and reports for regulatory and technical compliance

*Support development and validation of product and process test methods

Manufacturing & Supplier Quality*Support Design for Manufacturability initiatives

*Lead supplier quality activities including PPAP and tooling qualification

*Participate in supplier selection and specification reviews

CAPA & Non-Conformance*Lead investigations into complex product issues and nonconformances

*Drive root cause analysis and corrective actions

*Review and disposition nonconforming materials in pilot and clinical builds

Continuous Improvement*Identify opportunities to strengthen design control processes

*Apply statistical analysis and quality tools to support data-driven decisions

*Drive continuous improvement initiatives across engineering and quality systems

What We’re Looking For*5+ years’ experience in Quality Engineering within the medical device industry

*Strong knowledge of design controls, risk management, and medical device manufacturing

*Solid understanding of FDA and international regulatory frameworks

*Excellent analytical, problem-solving, and technical communication skills

*Bachelor’s degree or higher in Engineering, Science, or a related field

Compensation & Benefits*Competitive base salary aligned with senior medical device quality leadership roles

*10% annual performance bonus

*Excellent global benefits package including comprehensive healthcare, retirement plans, and wellbeing support

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
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