At a Glance
- Tasks: Join a global medical device company and ensure product quality through validation and compliance.
- Company: Innovative medical device company in Witney with a collaborative culture.
- Benefits: Competitive salary, full-time hours, and opportunities for professional growth.
- Other info: 12-month contract with potential for career advancement.
- Why this job: Make a real impact on healthcare products while working with diverse teams.
- Qualifications: Experience in quality engineering and a strong understanding of validation principles.
The predicted salary is between 33000 - 60000 £ per year.
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.
Randstad Business Support is acting as an Employment Business in relation to this vacancy.
Test validation engineer in Witney employer: Jobiqo
Bromley Council is an exceptional employer, dedicated to fostering a supportive and inclusive work environment where employees can thrive. With a strong commitment to professional development, flexible working arrangements, and a generous benefits package, including a local government pension scheme and unique discounts, the Council prioritises employee well-being and career growth. Located in the vibrant Bromley Civic Centre, you will be part of a team that plays a crucial role in shaping the future of the borough while enjoying the balance of urban and suburban life.
