Quality Engineer - Design & Test Validation

Description:

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 is a highly collaborative, cross-functional role where you will support a range of processes from R+D to clinical groups to transport and sterilisation.

We are looking for a professional who has interest in supporting Design Validation or Test Method Validation (TMV), who can make critical quality and compliance decisions during product development, validation, and testing. Acting as a Subject Matter Expert (SME), you will manage project activities to ensure our processes meet both business and customer needs flawlessly.

Role Details:

Location: Witney, Oxfordshire

Salary: £33,000 - £60,000 per annum Hours: Full-Time, 37.5 hours per week (Monday to Friday)

Contract Length: 12 Months

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 successful, 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 Subject Matter Expert (SME) during audits, cross-functional meetings, and site/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 (EHS) 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 with a dedicated focus on design validation or test method validation.
Prior experience in the development and/or manufacture of regulated products, demonstrating a strong 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.
Secondary level education including English and Maths (or equivalent).
Relevant Degree or equivalent qualification.
Note: The wide salary band reflects our openness to considering both intermediate and senior-level engineers. Salary will be closely aligned with your 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

How to Apply

If you are a validation specialist who thrives in a collaborative, cross-functional environment and has experience navigating regulated QMS environments, we want to hear from you.

Randstad Business Support is acting as an Employment Business in relation to this vacancy