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.
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