Quality assurance officer

• Oversee QA activities in compliance with ISO 13485:2016, BIS (Bureau of Indian Standards), and CDSCO (Central Drugs Standard Control Organization) regulations.
• Prepare and manage documentation required for regulatory submissions, audits, and inspections.
• Act as a key contact for regulatory and customer audits, including ISO, BIS, and CDSCO inspections.
• Handle audit findings and lead non-conformance (NC) investigations, root cause analysis, and corrective and preventive actions (CAPA).
• Ensure timely closure of NCs and maintain audit response documentation.
• Participate in the development, implementation, and maintenance of the company’s Quality Management System (QMS).
• Collaborate with cross-functional teams (production, R&D, RA) to ensure compliance across product lifecycle.
• Support risk management activities as per ISO 13485.
• Assist in training internal teams on QMS and regulatory compliance requirements.
• Monitor updates to applicable standards and regulations and implement necessary changes to QMS.

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Job Type: Full-time

Pay: ₹30,000.00 - ₹60,000.00 per month

Benefits:

• Cell phone reimbursement
• Food provided
• Provident Fund

Work Location: In person

Application Deadline: 30/08/2025
Expected Start Date: 08/08/2025