QARA Specialist

Job description

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.

Extra information

Status

Open

Education Level

Secondary School

Location

Greater Bristol Area

Type of Contract

Full-time jobs

Published at

09-02-2026

Full UK/EU driving license preferred

No

Car Preferred

No

Must be eligible to work in the EU

No

Cover Letter Required

No

Languages

English