Job Details

Key Responsibilities
1. Quality Assurance (QA)

• Maintain and implement the Quality Management System (QMS) in compliance with ISO 13485.
• Ensure compliance with FDA 21 CFR Part 820 and applicable regulatory requirements.
• Manage document control and records management.
• Conduct internal audits and support external audits (regulatory & customer audits).
• Lead CAPA (Corrective and Preventive Action) investigations and follow-up.
• Handle non-conformance reports (NCR) and deviation management.
• Support risk management activities (ISO 14971).
• Review and approve SOPs, work instructions, and quality documentation.
• Participate in Management Review meetings.
• Ensure proper training and competency records of staff.

2. Quality Control (QC)

• Perform incoming, in-process, and final product inspections.
• Ensure inspection and testing procedures comply with specifications.
• Monitor environmental controls (if applicable: cleanroom monitoring).
• Maintain calibration of inspection and testing equipment.
• Conduct sampling and statistical analysis (SPC).
• Verify batch records and device history records (DHR).
• Approve product release after verification.

3. Regulatory & Compliance

• Assist in product registration and regulatory submissions.
• Ensure labeling and packaging compliance.
• Maintain technical files and device master records (DMR).
• Monitor changes in regulatory requirements and update QMS accordingly.

4. Supplier Quality

• Perform supplier evaluation and audits.
• Monitor supplier performance.
• Manage supplier corrective actions.

5. Continuous Improvement

• Drive quality improvement initiatives.
• Analyze quality data and recommend corrective actions.
• Reduce defects and improve process efficiency.