Description
Key Responsibilities:
QMS Management:
- Create, implement, and maintain quality procedures and documentation.
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, MDSAP, and other regulatory standards.
CAPA & Non-Conformance Oversight:
- Manage CAPA processes including initiation, investigation, and resolution.
- Monitor timelines, track effectiveness, and report progress.
Audit Support:
- Assist with internal and external audits, including preparation and follow-up.
- Act as deputy in Management Review meetings.
Continuous Improvement:
- Identify process improvement opportunities and track key performance indicators.
Qualifications:
- Minimum 2 years' experience in Quality Assurance, preferably in the Medical Devices industry.
- In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and MDSAP.
- Experience in CAPA management, auditing, document control, and continuous improvement.