Supplier Quality Engineer
Oxfordshire | Hybrid Working | Permanent
I'm currently working with an innovative and fast‑growing medical device organisation in Oxfordshire that's looking to appoint a Supplier Quality Engineer as part of its continued expansion.
This is a fantastic opportunity to join a purpose‑driven business developing sophisticated implantable technology that genuinely improves patient lives. The company operates in a highly regulated environment and is moving into an exciting stage of clinical and manufacturing growth.
The Opportunity
As Supplier Quality Engineer, you will take ownership of the supplier quality management programme, working closely with Engineering, Manufacturing and Quality teams to ensure suppliers consistently meet regulatory, technical and quality requirements.
The role offers a hybrid working model, typically 3 days per week on site at a state‑of‑the‑art Oxfordshire facility, with regular UK and international travel to supplier sites.
Key Responsibilities
- Lead supplier evaluation and onboarding activities
- Plan and conduct supplier audits (remote and on‑site)
- Manage supplier quality agreements and corrective actions (SCARs)
- Act as the quality interface between suppliers and internal R&D and Manufacturing Engineering teams
- Support design for manufacture through quality input into design reviews and risk management
- Oversee supplier CAPAs, non‑conformances and complaint investigations
- Support internal audits and preparation for external inspections
- Analyse and report supplier performance trends to senior stakeholders
- Ensure supplier compliance with ISO 13485 and FDA 21 CFR Part 820
- Support supplier process validations (IQ/OQ/PQ) and capability studies (Cp/Cpk)
- Where required, spend short periods working directly at supplier sites to oversee quality‑critical work
What I'm Looking For
Essential
- Degree in an engineering discipline (Mechanical, Biomedical, Electrical, Industrial or similar)
- Proven experience in supplier quality engineering within a regulated industry (medical devices, aerospace, defence, etc.)
- Strong experience conducting external supplier audits
- Solid understanding of CAPA, non‑conformances, complaints and change control
- Ability to interpret engineering drawings, tolerances and specifications
- Willingness to travel regularly in the UK and internationally
Desirable
- ISO Lead Auditor certification
- Six Sigma Green Belt (or above)
- Experience with medical device materials and manufacturing processes
- Knowledge of ISO 13485, MDR, UKCA and FDA 21 CFR Part 820
You'll suit this role if you're confident dealing with suppliers, enjoy working cross‑functionally, and thrive in a fast‑paced, collaborative environment.
What's On Offer
- Competitive salary based on experience
- Hybrid working model
- Private healthcare
- Life assurance and income protection
- Company pension scheme
- Equity participation scheme
- 27 days annual leave plus bank holidays
- The chance to play a key role in delivering genuinely life‑changing technology
If you're a Supplier Quality Engineer looking for your next step in a growing medical device business, I'd love to talk you through the role in more detail.
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