QMS Officer

About the Job

Position: QMS Officer

Location: Ernakulam, Kerala

Work Mode: On-Site

We are looking for a proactive and detail-oriented QMS Officer to support our Quality Management System (QMS) activities and ensure compliance with international and national medical device regulations. This on-site role in Kochi, Kerala, involves working closely with the cross-functional teams including hardware, software, and regulatory affairs.

Key Responsibilities

QMS Maintaining and updating QMS documentation in line with ISO 13485 and FDA 21 CFR Part 820.

Compliance Support Ensure regulatory compliance with CDSCO (India), EU MDR, and other applicable standards.

Documentation Control Maintain controlled documents, records, and logs for audits and inspections.

Internal Audits Support internal audits, prepare checklists, and document findings.

CAPA Follow-Up Assist in tracking non-conformances, CAPAs, and improvement actions.

Training Support Coordinate quality training sessions and help with training records.

Supplier Coordination Assist in gathering supplier quality documentation and monitoring partner compliance.

Qualifications

Education: Bachelor's degree in Life Sciences, Engineering, or a related discipline.

Experience: 13 years of experience in a regulated industry, preferably medical devices or healthcare.

Skills: Familiarity with QMS principles, ISO 13485, and basic understanding of risk management and software testing and validation is a plus.

Soft Skills: Good organizational skills, attention to detail, willingness to learn and adapt, and team collaboration.

Work Mode: On-site role based in Kochi, Kerala.

Travel: Occasional travel may be required for audits or supplier visits.