Principal Quality Associate
đź“Ť Bicester (On-site)
🏠Medical Devices | Quality & Compliance
We’re looking for an experienced Principal Quality Associate to join our Quality team at our Bicester site, playing a key role in maintaining and strengthening quality and compliance across the business.
Reporting to the Compliance Director, you’ll work closely with Quality Control, Manufacturing and Suppliers to ensure products meet regulatory and customer requirements — from incoming inspection through to goods release, audits, and corrective actions.
This is a hands-on, influential role for someone who thrives in a regulated environment and enjoys turning quality requirements into practical, compliant processes.
What You’ll Be Responsible For
* Supporting incoming inspection and goods release activities in collaboration with the Quality Control team
* Investigating product non-conformities and driving effective corrective and preventive actions (CAPA)
* Developing, implementing and maintaining compliant quality processes aligned to regulatory standards
* Planning, conducting and completing internal audits and supplier audits
* Supporting external audits, including preparation of documentation and participation during assessments
* Logging, investigating and documenting non-conformities (NCs) and CAPAs, ensuring timely resolution
* Monitoring and maintaining goods-in quality metrics, preparing data for quality and management reviews
* Conducting supplier evaluations and supporting supplier compliance meetings with relevant data and insights
* Coordinating Quality Control tasks to ensure product holds are resolved efficiently and compliantly
* Supporting quality activities at GBUK acquisition sites
* Undertaking additional quality-related tasks as required by the Head of Quality or Compliance Director
What We’re Looking For
Essential
* Experience working in a Quality role within the Medical Device industry
* Strong working knowledge of a recognised QMS (ISO 13485 or ISO 9001 as a minimum)
* Experience conducting internal audits (Lead Auditor level desirable)
* Hands-on experience with CAPA, non-conformities and root cause analysis
* Experience writing and implementing processes compliant with standards
* Excellent attention to detail with a structured, methodical approach
* Strong communication skills and the ability to work effectively across teams
* A proactive, problem-solving mindset with the ability to manage multiple priorities
Desirable
* Knowledge and experience of MDR
* Experience or knowledge of FDA incident reporting
* Supplier audit experience
Why Join Us?
* A senior, influential quality role with real impact
* Close collaboration with manufacturing, suppliers and leadership
* A business that values practical quality, not just paperwork
* Opportunity to support quality across a growing organisation
Important
👉 Candidates must be based in or able to commute to the Bicester area.
This is an on-site role.