Job Description
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.
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 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
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