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.