Position Type: 12-Month Initial Contract (With high potential for extensions or permanent conversion)
Salary: £35,000 – £66,000 per annum (Dependent on experience, entry level and seasoned professionals considered)
Location: Witney, on site full time
About the Role
We are seeking a Validation Quality Engineer to join a global leader in healthcare and medical technology. In this role, you will be embedded within a highly collaborative team of 5 QA and engineering professionals, working side‑by‑side with the software development teams who write the code for our life‑changing medical devices.
Your core mission is to act as the bridge between engineering and compliance. Rather than focusing on day‑to‑day manufacturing operations, this position is deeply embedded within R&D and project teams. You will ensure that software development teams strictly adhere to software validation system lifecycles and medical device regulatory standards, acting as a trusted consultant on validation strategy, change control activities, and protocol execution.
Our team is diverse, ranging from ambitious engineers with 2–3 years of experience to industry veterans with over 20 years of expertise. We are looking for someone with a solid foundation in regulated environments who can provide practical, proactive guidance to keep our projects moving safely and compliantly.
Key Responsibilities
- Project Consultation & Strategy: Embed within medical device project teams to provide strategic guidance on validation processes, helping teams navigate compliance pathways smoothly.
- Lifecycle Compliance: Ensure software teams are fully complying with software validation system lifecycles and strict medical device requirements.
- Protocol Development: Author, review, and execute robust validation protocols, reports, and technical documentation to meet rigorous quality standards.
- Change Control Management: Provide expert guidance on validation changes and lead change control activities in accordance with established quality management system (QMS) procedures.
- General QA Support: Collaborate closely with the wider Quality Assurance team to support audits, risk assessments, and continuous improvement initiatives.
What We Are Looking For
- Regulated Industry Experience: Experience working within a strictly regulated environment (highly prefer medical devices under ISO 13485 / FDA 21 CFR Part 820, though Pharmaceuticals or Aerospace will be considered).
- Validation Background: Proven track record as a Validation Engineer with direct experience writing validation protocols. Note: You do not need to be a software or systems specialist, but a strong understanding of general validation principles is essential.
- Lifecycle & Change Control Knowledge: Solid understanding of validation system lifecycles and the impact of change control in a regulated manufacturing/design environment.
- Collaborative Communicator: Ability to confidently guide, advise, and consult with software developers and project stakeholders on compliance strategy.
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