Quality Assurance Officer

3 days ago

Panipat, India BAMC Medical Limited Full time

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.

*

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

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