QA / QC Manager-Medical Devices

Role Overview :

Responsible for implementing and maintaining the Quality Management System (QMS) in compliance with ISO 13485 and regulatory standards. Ensures product quality, process integrity, and audit readiness across all manufacturing operations.

Key Responsibilities :

Oversee incoming, in-process, and final product inspections .

Ensure compliance with ISO 13485, ISO 14971, and GMP guidelines.

Review and approve SOPs, batch records, and quality documentation .

Manage deviations, CAPA, and root cause analysis .

Support validation and qualification of equipment and processes.

Lead internal and supplier audits , and support regulatory inspections.

Drive continuous improvement initiatives in quality systems.

Qualifications :

B.Pharm / M.Pharm / B.Tech (Biomedical, Biotechnology, or Life Sciences).

Minimum 6 years’ QA / QC experience in medical device manufacturing .

Strong understanding of QMS documentation and validation protocols .

Internal auditor certification (ISO 13485) preferred.