Job description:

- Document handling: Creation, revision, and control of quality system documents needed to ensure product quality and adherence to applicable regulations.
- Conduct Internal Quality Audits and Management Review Meetings on defined intervals and record meeting minutes.
- Monitor and maintain the Quality Management System up to date to facilitate any Internal or External audits.
- Maintaining the regulatory and statutory submissions up to date.
- Handling of Non-conformance, CAPAs, Change controls and Customer complaints in compliance with ISO 13485.
- Effective handling of suppliers; involving supplier audits, supplier onboarding, supplier monitoring, etc.
- Risk management: Proactively identifying the potential hazards associated with the design or process and evaluating the risk assessment strategy.
- Design and development: Participating in the Design Review Meetings and Co-ordinating with the product management team in reviewing the design related documents.




- Conduct/co-ordinate with the equipment and process qualification process.
- Review of batch/quality records and authorizing the final release of the product.

Competency requirements:

Skills required:

Mandatory:

- Good knowledge on ISO 13485:2016
- Fair knowledge on 21 CFR 820, 21 CFR part 11, IVDR and MDR
- Fair knowledge on cGMP, GDP and GLP

Additional:

- Valuable communication skill
- Knowledge on ISO 14971 Risk Management
- Knowledge on online documentation
- Handling of process and material transactions in ERP

Qualification required:

Bachelor’s or Master’s in science relevant fields.

Experience required:

8 to 10 years of experience in the medical device manufacturing company as Quality Assurance.

Pay: ₹800,000.00 - ₹1,600,000.00 per year

Benefits:

- Health insurance
- Leave encashment
- Provident Fund

Work Location: In person

📌 Quality Head (India)
🏢 Jana Med Tech
📍 India