Quality Engineer – Design & Test Validation

Quality Engineer (12-Month Contract)

Location: Witney, Oxfordshire

Salary: £33,000 – £60,000 per annum (Dependent on Experience)

Hours: Full-Time, 37.5 hours per week (Monday to Friday)

Contract Length: 12 Months

We are seeking a skilled and adaptable Quality Engineer to join a global medical device company based in Witney. This highly collaborative, cross‑functional role supports a range of processes from R&D to clinical groups, transport and sterilisation.

Key Responsibilities

• Validation & Compliance Decisions: Make definitive quality and compliance decisions on products throughout development, validation, processing, and testing phases.
• Cross‑Functional Project Management: Project‑manage cross‑functional activities to agreed timelines, utilising appropriate risk‑management tools to prioritise efforts and safeguard quality.
• Relationship Management: Maintain collaborative relationships with cross‑functional departments, including R&D, Technical, Engineering, Operations, and Regulatory Affairs, to achieve project milestones.
• QMS Monitoring & Improvement: Review, approve, and assess the impact of changes or corrections to documentation, processes, or systems to ensure effective and compliant QMS procedures.
• Audit & Expert Representation: Act as the SME during audits, cross‑functional meetings, and site or divisional‑level projects.
• Meticulous Record Keeping: Ensure all record‑completion strictly adheres to defined procedures and quality standards, securing and storing data appropriately.
• EHS & Ethics: Maintain safe working environments by supporting Environment, Health and Safety performance and ensuring all business behaviours align strictly with the corporate Code of Conduct.

What We Are Looking For

• Proven experience as a Quality Engineer, dedicated to design validation or test‑method validation.
• Experience in the development and/or manufacture of regulated products, demonstrating familiarity with cGMP and/or ISO quality‑system requirements.
• Demonstrated ability to build and maintain relationships across multiple engineering and technical disciplines.
• Strong technical understanding of validation principles, statistics, and risk‑management tools.
• Level of education: Secondary level education including English and Maths (or equivalent); relevant degree or equivalent qualification.
• Note: The wide salary band reflects openness to both intermediate and senior‑level engineers; salary will be aligned with specific depth of experience.

What’s on Offer

Work‑Life Balance: Standard 37.5‑hour work week with a dependable Monday to Friday schedule.

Onsite Perks & Benefits

• Onsite parking
• Electric vehicle charging stations
• Subsidised canteen
• Free Lavazza coffee machines

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