QUALITY ENGINEER – MEDICAL DEVICES

Our client is a start-up developing breakthrough medical devices for plastic and reconstructive surgery. To strengthen its Quality & Regulatory Affairs Team, the company is looking for a highly motivated Quality Engineer to support R&D activities and maintain a robust QMS for Class III medical devices.

Key Responsibilities

• Support the development, implementation and monitoring of the QMS in compliance with ISO 13485, 21 CFR Part 820 and MDR 2017/745.

• Drive QA activities across Teams, review/approve quality documentation and ensure adherence to procedures.

• Lead Change Control and Non-Conformity processes and support risk management activities.

• Monitor and report Quality KPIs and contribute to continuous QMS improvement.

• Manage supplier qualification, evaluation and annual assessments; review Quality Agreements and act as the main Quality contact for suppliers.

• Support internal, supplier and Notified Body audits, including planning, preparation and execution.

• Provide Design Control support throughout product development, including DHF management, traceability and Design Verification activities.

• Coordinate testing activities with qualified subcontractors and follow up stability studies, including protocols, reports and data analysis.

• Train Teams on QMS requirements and contribute to building a strong quality culture.

• Provide solution-oriented QA support and contribute to the preparation/review of QMS and technical documentation.

• Provide ad-hoc support to Quality Control, Clinical and Regulatory activities.

Profile

• Engineering degree or Bachelor/Master in Science, Quality Assurance or Regulatory Affairs.

• 3–5 years’ experience in QA within Pharma, Biotech or Medical Devices.

• Strong knowledge of MDR 2017/745, 21 CFR, ISO 13485 and ISO 14971.

• Experience with QMS development/maintenance and medical device Design Control.

• Strong analytical, organisational and communication skills; rigorous, proactive and autonomous.

• Problem-solver, results-oriented and comfortable working in multidisciplinary teams.

• Fluent written and spoken English required.

We offer

A dynamic, innovative environment at the forefront of biomedical technology, with opportunities to grow, contribute ideas and make a meaningful impact on patients’ lives.