- Lead and manage the Quality Assurance department.
- Ensure compliance with ISO 13485, GMP, MDR, and applicable regulatory requirements.
- Develop, implement, and maintain Quality Management Systems (QMS).
- Review and approve quality-related documents, SOPs, protocols, and reports.
- Handle internal, external, customer, and regulatory audits.
- Monitor CAPA, Change Control, Deviations, and Risk Management activities.
- Coordinate with Production, QC, R&D, Regulatory Affairs, and Supply Chain teams.
- Drive continuous improvement initiatives and quality objectives.
- Manage customer complaints, non-conformance investigations, and corrective actions.
- Train and develop QA team members.
- Ensure compliance with company policies and quality standards.
Required Qualifications
- Bachelor's or Master's Degree in Engineering, Pharmacy, Biotechnology, Life Sciences, or related field.
- 10–15 years of experience in Quality Assurance within Medical Devices, Pharmaceuticals, or Healthcare Manufacturing.
- Minimum 5 years of experience in a leadership role.
- Strong knowledge of ISO 13485, GMP, QMS, CAPA, Risk Management, and Regulatory Compliance.
- Excellent leadership, communication, and problem-solving skills.
Preferred Skills
- Experience handling ISO, CE, FDA, and customer audits.
- Strong documentation and quality system management skills.
- Ability to lead cross-functional teams.
- Strategic thinking and decision-making capabilities.
Pay: ₹1,500,000.00 - ₹1,700,000.00 per year
Work Location: In person
