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