Job Title: - GM- Quality Assurance (Medical devices)
Job Description
The General Manager – The Quality Assurance Manager is responsible for overseeing quality systems and manufacturing quality for PCB assembly, sub-assembly, and final medical device assembly. The role ensures that products are manufactured in compliance with applicable quality standards, regulatory requirements, and customer specifications, while maintaining a robust Quality Management System aligned with ISO 13485 and regulatory requirements from authorities such as Central Drugs Standard Control Organization and U.S. Food and Drug Administration, 21 CFR Part 820.
Roles & Responsibility
Quality Assurance & Quality Management System
- Maintain and improve the Quality Management System in compliance with ISO 13485.
- Ensure adherence to quality procedures, SOPs, and documentation across manufacturing operations.
- Ensure compliance with applicable regulatory requirements including 21 CFR Part 820. and EU Medical Device Regulation where applicable.
- Oversee document control, change control, and training system. Also maintain quality policies, procedures, and documentation.
- Ensure data integrity, documentation control, and record retention.
- Design transfer and New Product Introduction (NPI) quality readiness.
- Data integrity and documentation governance aligned with FDA expectations.
- Prepare quality metrics and reports for management review meetings.
- Monitor KPIs such as complaints, CAPA closure, non-conformance rates, and audit outcomes.
- Review and approve MIS reports and present quality/regulatory updates to leadership.
- Coordinate with Production, QC, R&D, Supply Chain, and Materials departments.
Regulatory Compliance
- Ensure manufacturing operations comply with regulatory requirements from authorities such as U.S. Food and Drug Administration, Central Drugs Standard Control Organization, and global regulatory bodies.
- Support regulatory submissions and product registrations.
- Monitor regulatory updates and implement changes in the QMS.
Quality Control Oversight
- Oversee incoming, in-process and final product inspections.
- Ensure appropriate test methods, acceptance criteria, and quality standards are followed.
- Approve product release as per defined procedures.
Audits & Inspections
- Lead and manage external audits (ISO, Auditing bodies, customers, clients)
- Ensure timely closure of audit non-conformities (NCs)
- Plan and execute internal audits across all departments at defined intervals
- Ensure full compliance with laws, regulations, SOPs, and industry guidelines
Supplier Quality Management
- Qualify and monitor suppliers.
- Conduct supplier audits and supplier performance reviews.
- Ensure incoming materials meet specifications.
Required Certifications
Demonstrated expertise and/or formal training in relevant standards and quality systems as below
- ISO 13485:2016 Certified Lead / Internal Auditor
- GMP Certification
- ISO 14971 Risk Management Training
- CAPA & Root Cause Analysis Certification
