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:
Valuable 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

Advantages:
Health insurance
Leave encashment
Provident Fund

Work Location: In person

📌 Quality Head Bengaluru
🏢 Jana Med Tech
📍 Bengaluru