Found Description
Responsibilities
- Maintain, implement and continually improve the Quality Management System (QMS) in accordance with ISO 9001, ISO 13485 and applicable customer/regulatory requirements. Ensure quality procedures, work instructions, forms and controlled documents are properly established, reviewed, approved, maintained and updated.
- Manage document control activities including document revision, distribution and obsolescence control.
- Monitor the effectiveness of QMS processes through KPI monitoring, trend analysis, and performance reporting. Coordinate certification, surveillance, customer, and regulatory audits.
- Plan, coordinate and conduct internal quality audits.
- Coordinate certification, surveillance and customer audits.
- Liaise with certification bodies, customers and regulatory auditors.
- Ensure compliance with applicable quality management standards, customer‑specific requirements, and regulatory requirements. Coord...
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