JOB DESCRIPTION_ Quality Assurance

Position: Quality Assurance

Department: Quality Assurance

Industry: Medical Devices / IVD

Experience: 23 Years

Employment Type: Full-Time

Work Location: SIPCOT Medical Device Industrial Park, Oragadam, Tamil Nadu

About the Role

We are looking for a detail-oriented and responsible Quality Assurance professional with 2 to 3 years of relevant experience in the Medical Device / IVD industry. The candidate will be responsible for maintaining and improving the Quality Management System (QMS), ensuring compliance with applicable regulatory and quality requirements, and supporting continuous improvement activities.

Key Responsibilities

- Implement and maintain the Quality Management System (QMS) in accordance with applicable standards and company procedures.
- Ensure compliance with ISO 13485, GMP, and applicable regulatory requirements.
- Prepare, review, control, and maintain quality-related documents and records.
- Review and approve SOPs, Work Instructions, specifications, batch/production records, and quality documents.
- Monitor and manage Non-Conformities (NCs), deviations, CAPA, and change controls.
- Support and conduct internal audits and assist during customer, certification, and regulatory audits.
- Coordinate with Production, QC, R&D;, Regulatory Affairs, and other departments on quality-related activities.
- Support process validation, equipment qualification, and related quality activities.
- Ensure proper implementation of document control and record control procedures.
- Participate in risk management and quality improvement activities.
- Investigate quality issues and assist in identifying root causes and corrective/preventive actions.
- Monitor quality objectives and relevant quality performance indicators.




- Ensure proper handling and closure of quality-related complaints and observations.
- Conduct and maintain relevant quality training records for employees.
- Promote a strong quality culture and continuous improvement within the organization.

Educational Qualification

- Bachelor's or Master's degree in Life Sciences, Biotechnology, Biochemistry, Microbiology, Pharmacy, Biomedical Engineering, or a relevant discipline.
- Additional qualification/training in Quality Management or Medical Device Quality Assurance will be an advantage.

Required Experience & Skills

- 2 to 3 years of relevant experience in the Medical Device / IVD industry.
- Good knowledge of ISO 13485 and Quality Management Systems.
- Understanding of GMP, CAPA, Non-Conformance, Change Control, Risk Management, and Internal Auditing.
- Experience in quality documentation and document control.
- Good analytical, problem-solving, and decision-making skills.
- Solid attention to detail and ability to maintain accurate records.
- Good communication and coordination skills.
- Ability to work independently as well as collaboratively with cross-functional teams.

Preferred

- Experience in IVD / Diagnostic Kit manufacturing will be an added advantage.
- Knowledge of IVDR / applicable medical device regulatory requirements will be preferred.
- Experience in handling ISO 13485 certification and regulatory/customer audits will be an advantage.

What We Offer

- Opportunity to work in the Medical Device / IVD industry.
- Professional growth and learning opportunities.
- Exposure to QMS, regulatory compliance, audits, and quality improvement activities.
- Collaborative and quality-focused work environment.

Job Location Genuine Biosystem Pvt. Ltd.

SIPCOT Medical Device Industrial Park,

Oragadam, Tamil Nadu.

📌 Quality Assurance Executive and Regulatory Affairs (Chennai)
🏢 GENUINE BIOSYSTEM
📍 Chennai