Lead Design Quality Engineer - Medical DevicesHybrid 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.

You will work closely with R&D, manufacturing, and supplier partners, shaping quality strategy across design controls, risk management, verification & validation, and supplier quality.

• 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

• 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

• 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

• Support Design for Manufacturability initiatives

• Lead supplier quality activities including PPAP and tooling qualification

• Participate in supplier selection and specification reviews

• 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

• 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

• 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

• 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

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