A great opportunity for an QARA professional to step into a hands-on role within a medical device environment.
Hybrid (up to 2 days WFH) near Bristol
This role sits at the heart of manufacturing, supplier oversight and regulatory support, with a strong quality focus (70%) and exposure to UK, EU and global regulatory activities. (30%)
What you’ll be doing:
* Day-to-day ownership of ISO 13485 / GMP-aligned QMS activities
* Supporting validation (equipment, process & software)
* Managing and supporting internal, supplier & Notified Body audits
* Handling complaints, RCA and CAPAs
* Maintaining controlled documentation within an eQMS
* Supporting supplier quality and production quality activities
* Contributing to regulatory documentation, PMS and labelling reviews
What we’re looking for:
* 3 years’ experience in a Quality role within medical devices
* Working knowledge of ISO 13485, GMP and medical device regulations (MDR / UK MDR / FDA exposure a plus)
* Experience across validation, audits, complaints and document control
* Someone confident working independently, detail-driven and solutions-focused
This is a strong role for someone looking to deepen their medical device quality experience while gaining broader regulatory exposure.