QA and Regulatory Officer

Introduction

To own, drive, and ensure effective closure of CAPAs, nonconformances and customer complaints, while maintaining and continuously improving the Quality Management System in compliance with ISO 13485 and MDSAP. This role requires a technical/mechanical engineering background to support long-term implantable medical devices, including machined and additively manufactured components, and to draft manufacturing and equipment validation documentation.

Duties & Responsibilities

• Drive ownership and timely closure of CAPAs, nonconformances and customer complaints, ensuring robust root cause analysis and effectiveness checks.
• Draft, review and approve manufacturing, process, packaging, sterilisation and equipment validation protocols and reports (IQ/OQ/PQ).
• Provide technical QA oversight for machined and additively manufactured long-term implantable medical devices.
• Continue implementation and maturation of the MDSAP programme...