Job Description

We are hiring an experienced QC Manager from the Medical Device industry to lead end-to-end Quality Control operations at our Daman plant. The ideal candidate will have strong expertise in quality systems, inspection planning, GMP compliance, regulatory documentation, and implementation of medical device standards such as ISO 13485.

Key Responsibilities

Lead and manage QC operations for incoming materials, in-process checks, and finished medical devices.
Ensure compliance with ISO 13485, GMP, FDA, MDR, and company quality standards.
Implement and monitor quality control procedures, test methods, and inspection protocols.
Oversee calibration of measuring equipment and maintain documentation.
Handle product validation, sample testing, stability testing, and batch release.
Investigate quality deviations, non-conformities, and implement CAPA.
Conduct audits: internal, supplier, and process audits.
Manage QC team performance, training, and workflow allocation.
Coordinate with Production, QA, R&D, and Regulatory teams to ensure quality assurance at all stages.
Prepare quality reports, MIS, and present quality performance data to management.

8–10 years of QC experience specifically from Medical Device Manufacturing.
Strong knowledge of ISO 13485, GMP, risk management, and regulatory requirements.
Hands-on experience in testing, inspection, calibration, and validation.
Ability to handle audits and compliance documentation.
Excellent communication, team-handling, and problem-solving skills.
Bachelor’s or Master’s degree in Science / Engineering (Biomedical, Mechanical, or related fields).

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