Quality Engineer

Are you passionate about quality and compliance in the medical device industry? Do you thrive in a dynamic environment where your attention to detail and problem-solving skills make a real impact?

We are recruiting for a start-up Medical Device company who are committed to improving patient outcomes through innovative medical technologies.

What You'll Do:

As a Quality Engineer, you'll play a key role in both Quality Assurance and Quality Control functions, ensuring product safety and regulatory compliance. Your responsibilities will include:

Leading supplier management activities (SCARs, KPIs, audits, agreements)
Investigating complaints, non-conformances, and CAPAs
Inspecting and releasing products and labels
Reviewing Device History Records and equipment documentation
Supporting internal and external audits
Driving continuous improvement of the Quality Management System (QMS)

What We're Looking For:

Essential:

Experience with ISO13485 and 21 CFR Part 820
QA (and ideally QC) experience in a medical device company
Degree or relevant quality qualificationDesirable:

4+ years in a quality role within medical devices
Supplier evaluation and monitoring expertise
ISO13485 Lead Auditor training

Key Competencies:

✅ High attention to detail
✅ Strong collaboration and communication skills
✅ Analytical and critical thinking
✅ Ability to work independently and cross-functionally

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy