Job Location: Boisar

Job Type: Full Time

Qualification: B.Sc. in Chemistry or Biochemistry

Experience: 2 - 3 Years

Job Overview

We are looking for a detail-oriented QA Officer having 2-3 Years of experience to support quality assurance, documentation, and regulatory compliance activities, and to help maintain our Quality Management System (QMS). The role covers product and process quality for our IVD portfolio - clinical chemistry reagents and rapid POCT devices - ensuring compliance with ISO 13485:2016, Indian MDR 2017, internal SOPs, and other applicable quality standards.

Key Responsibilities

- Support regulatory activities, including obtaining and maintaining licenses under Indian MDR 2017 (Manufacturing License, NCC, MSC, Test License, Import License) and other related regulatory tasks.
- Monitor, evaluate, and support implementation of ISO 13485:2016 requirements across the organization s QMS.
- Identify gaps and improvement opportunities within the QMS, and contribute to corrective and preventive actions.
- Prepare and review SOPs, work instructions, and quality formats/templates as required.




- Carry out routine QA activities, including batch assignment, batch record documentation (BPR/BMR), in-process quality assurance (IPQA), document issuance and control, and label/PD (packing detail) verification.
- Monitor and support implementation of 5S practices across the organization.

Requirements

- 2-3 years of experience in QA/regulatory affairs, preferably within the IVD, medical device.
- Working knowledge of ISO 13485:2016 and Indian MDR 2017.
- Solid documentation and technical writing skills (SOPs, batch records, quality formats).
- Detail-oriented with strong organizational and problem-solving skills.
- Good communication skills and ability to work collaboratively across departments.

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

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