quality engineer

Job description

1. Production Quality Oversight

• Supervise in-process inspection, final inspection, and product release activities.
• Monitor quality performance, implement corrective and preventive actions (CAPA) for non-conformities.
• Conduct first article inspections (FAI) and oversee approval of molded components.

2. Documentation & Reporting

• Ensure accurate and timely completion of quality records, inspection reports, and batch documentation.
• Maintain device history records (DHR) and support device master record (DMR) updates as needed.
• Lead root cause investigations and document findings in quality reports.

3. Team Management & Training

• Supervise and train quality inspectors and technicians to ensure competency in inspection and quality control tasks.
• Conduct training on SOPs, GMP, GDP, and cleanroom behavior as needed.
• Assign daily inspection tasks and veri...