Work with commercial teams to ensure implementation and/or maintenance of QMS that are appropriate for Medical Devices / Life Sciences Manufacturing / Medical Devices Distribution and Services, ISO9001, IVDR and other applicable regulatory and statutory requirements.
- Coordinate, plan and manage audits (internal/cross-sites).
- Facilitate external audit by certification body and support regulatory inspections by regulatory agencies
- Perform internal audits of processes, facilities and documentation to assure compliance with internal procedures and regulatory requirements.
- Establish, maintain and update relevant QMS documentation.
- Coordinate the Quality Management Review meeting on scheduled basis and prepares metrics and reports.
- LMS administrative role for local procedure and practice.
- Conduct customer feedback/complaints and trend review, and drive appropriate continual improvement implementation.
- Support all Quality compliance and regulatory activities.
Language requirements:
Fluent English is mandatory, both spoken and written
Fluent of French or Spanish or Italiano is highly preferred