To ensure orthopedic medical devices (implants and instruments) conform to specified quality standards and are safe, sterile, and compliant with global regulatory requirements. The QC Executive is responsible for inspection, testing, and documentation of components and finished products at various stages of manufacturing.
Responsibilities:
1. Incoming Material & Component Inspection
Inspect raw materials (stainless steel, titanium, PEEK, etc.) and orthopedic components (plates, screws, rods, etc.) for dimensional and material compliance.
Verify CoAs, MTCs, and third-party test certificates.
2. In-Process & Final Product Inspection
Conduct in-process quality checks during machining, polishing, passivation, laser marking, and packaging.
Perform final inspection of implants and surgical instruments using precision measuring tools (vernier, micrometer, height gauge, CMM).
Ensure compliance with drawings, tolerances, and finish quality.
3. Documentation & Regulatory Compliance
Maintain test records, inspection reports, and batch release documents per ISO 13485 and FDA 21 CFR Part 820 requirements.
Ensure traceability of components through DHR (Device History Records) and DMR (Device Master Records).
4. Testing & Validation Support
Assist in mechanical testing (e.g., hardness, tensile, torque, fatigue).
Support process and cleaning validation, and maintain reports.
5. Non-Conformance Management
Identify and report non-conformances (NCRs).
Assist in root cause analysis (RCA) and implementation of CAPA in coordination with QA.
6. Audit Readiness
Maintain audit-ready documentation.
Support internal audits and external inspections by regulatory bodies (CDSCO, Notified Body, US FDA, etc.).
Key Skills & Competencies:
Proficient in reading and interpreting engineering drawings (GD&T knowledge is a plus).
Attention to detail, good analytical and documentation skills.
🎓 Educational Qualification:
Diploma / B.Tech in Mechanical/ B.E in Mechanical