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.
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