Multinational medical device company is looking for an experienced Quality Assurance Manager to ensure that all medical devices manufactured at the facility comply with regulatory standards (FDA, ISO 13485, MDR, etc.). They oversee quality systems, lead audits, manage CAPA (Corrective and Preventive Actions), and ensure product safety and efficacy.

Reports To: Compliance Manager

Key Responsibilities:

Quality System Management:

• 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).
  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.