Lead Design Quality Engineer - Medical Devices

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 Opportunity You will work closely with R&D, manufacturing, and supplier partners, shaping quality strategy across design controls, risk management, verification & validation, and supplier quality. Key Responsibilities Design 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. We will contact you within the next 14 days if you are selected for interview. For a copy of our privacy policy please visit our website