Quality Assurance Manager

K Line Europe

Key Responsibilities:

• Maintain and improve the Quality Management System (QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR/IVDR, MDSAP, etc
• Develop and update Standard Operating Procedures (SOPs), Work Instructions (WIs), and Quality Policies. Ensure proper document control and record retention per regulatory requirements.

Regulatory Compliance & Audits:

• Lead internal/external audits (FDA, Notified Body, Customer Audits).
• Ensure compliance with risk management (ISO 14971).
• Prepare and support regulatory submissions (510(k), CE Marking, etc.).

Production & Process Quality Oversight:

• Monitor manufacturing processes to ensure adherence to GMP (Good Manufacturing Practices). Oversee incoming, in-process, and final product inspections.
• Manage non-conforming materials (NCMR) and product recalls if needed.

CAPA & Risk Management:

• Lead Corrective and Preventive Action (CAPA) investigations.
• Perform root cause analysis (e.g., 5 Whys, Fishbone Diagram). br>Track quality metrics (e.g., scrap rate, complaint trends).

Supplier & Material Quality:

• Conduct supplier audits and approve raw material suppliers.
• Ensure incoming material inspections meet specifications.

Training & Team Leadership:

• Train staff on QMS, GMP, and regulatory requirements.
• Supervise QA/QC personnel (inspectors, engineers).

Customer & Post-Market Surveillance:

• Monitor post-market surveillance data for trends.