Lead Design Quality Engineer - Medical Devices

Gold Group Ltd
Falmouth
12 hours ago
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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

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.

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