Inspection & Testing: Perform dimensional checks, hardness tests, surface finish inspections, and mechanical property evaluations of implants.
Compliance Assurance: Ensure adherence to ISO 13485, FDA 21 CFR Part 820, CE Marking, and other regulatory standards.
Process Validation: Validate CNC machining, polishing, passivation, and sterilization processes for orthopedic implants.
Documentation: Maintain inspection reports, calibration records, and batch release documentation.
Root Cause Analysis: Investigate non-conformities, implement corrective and preventive actions (CAPA).
Supplier Quality: Audit raw material suppliers (titanium, stainless steel, cobalt-chrome alloys) for compliance.
Continuous Improvement: Apply lean manufacturing and Six Sigma principles to reduce defects and improve yield.
In an Orthopedic Implant Manufacturing company, the benefits for employees are designed to reflect the highly regulated, precision-driven nature of the medical device industry. Since quality and compliance are critical, companies often provide a mix of professional, financial, and personal perks to attract and retain skilled engineers.
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