Experience: 12+ years in Quality Management, preferably in Medical Devices / Healthcare / Precision Manufacturing.
Key Responsibilities
Lead QA, QC and QMS activities across manufacturing operations.
Ensure compliance with ISO 9001, ISO 13485 and IATF 16949 requirements.
Plan and conduct internal, customer, supplier and certification audits.
Manage CAPA, NCR, 8D, Root Cause Analysis and corrective actions.
Drive quality improvement, process control and continuous improvement.
Manage QA measurement systems, calibration, MSA and Gauge R&R.
Monitor quality KPIs including rejection, rework, PPM, FPY and customer complaints.
Lead, mentor and develop the QA/QC team.
Coordinate with Production, Engineering, Suppliers and Customers to resolve quality issues.
Education: B.E./B.Tech in Mechanical, Production, Industrial or related engineering discipline preferred.