Quality Engineer Medical Devices Part or Full Time

5 days ago


London, United Kingdom SJB Technical Ltd Full time

**Quality Engineer Medical Devices Part or Full Time**
**SW London**
**£Neg plus benefits**
Our client is a dynamic and innovative early-stage medical devices company developing a cutting-edge medical device. As part of their continuing growth, they now have a requirement for a **Quality Engineer**approving new products for the EU and US Markets.

Working within an established, well-funded business, take a hands-on leadership role for the QMS and QA functions across the business with a high degree of autonomy and close interaction with the CTO, Head of Ops and CEO.

Liaising with the external vendors, stakeholders, regulatory bodies, and notified bodies frequently. This opportunity is a key role in a medical device scale-up who are destined for major growth.

The role would ideally suit someone seeking 3 or more days a week.

**Experience**
- Engineering/Science degree qualification (or industry experience equivalent) with solid experience within a medical device environment in a similar capacity.
- Knowledge of FDA Quality System Regulation, ISO 13485, ISO 14971, EU MDD, EU MDR.
- Qualified as an internal and external auditor
- Knowledge / experience in writing regulatory device submissions like CE certification, IDEs, and 510(k)

**Responsibilities**:

- Maintaining the efficiency of the Quality Management System (QMS) and implementing continuous improvement.
- Working closely with an external consultant on the CE Marking of the new products and FDA Submissions
- Responsible for FDA inspections, notified body audits, and other audits and inspections

Benefits: Share option scheme



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