QA Officer

Accurex Biomedical Pvt. Ltd.; Boisar; On-site; INR 280,000 - 310,000; Full time

Job summary

Accurex Biomedical Pvt. Ltd.

in Boisar, Maharashtra, seeks a detail-oriented QA Officer with 2–3 years of QA/regulatory experience to support quality assurance, documentation, and regulatory activities, helping maintain the QMS for our IVD portfolio including clinical chemistry reagents and rapid POCT devices. The role requires working knowledge of ISO 13485:2016 and Indian MDR 2017, strong documentation skills, and the ability to collaborate across departments to implement 5S and continuous

Qualifications

• 2–3 years of QA/regulatory experience in the IVD/medical device sector.
• Working knowledge of ISO 13485:2016 and Indian MDR 2017.
• Strong documentation and technical writing skills (SOPs, records, formats).
• Detail-oriented with good organizational and problem-solving abilities.
• Excellent communication and cross-department collaboration

Responsibilities

• Support regulatory activities, including licenses under Indian MDR 2017 and related tasks.
• Monitor ISO 13485:2016 requirements across the QMS.
• Identify gaps and drive corrective and preventive actions.
• Prepare and review SOPs, work instructions, and quality templates.
• Perform routine QA activities: batch records, IPQA, document control, and packing verification.
• Support 5S implementation across the organization

Skills

Detail-oriented

Documentation

Regulatory knowledge

Job description

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.
• Strong 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.

What We Offer

• Opportunities for professional growth and development
• A dynamic, collaborative work environment
• Exposure to end-to-end QA and regulatory processes in the IVD industry

Salary

Up to ₹2.8 - 3.1 (Salary will depend on experience and qualifications, and will fall within the specified range)