Quality Assurance Specialist

Quality Assurance Specialist

We are currently supporting a medical device company that is strengthening its QMS to ensure full compliance with EU regulatory requirements and continuous process improvement. To support this initiative, we are seeking a Quality Assurance & Regulatory Compliance Consultant to contribute to the implementation and maintenance of an ISO 13485-based QMS while supporting regulatory compliance activities under EU MDR (2017/745).

Responsibilities

• Support the implementation, maintenance, and continuous improvement of the QMS
• Develop and maintain quality documentation (SOPs, forms, records)
• Support supplier qualification activities and participate in internal and external audits
• Assist in CAPA management, complaint handling, and non-conformity processes
• Ensure compliance with ISO 13485 and EU MDR (2017/745)
• Support technical documentation maintenance and regulatory compliance activitie...