Role Summary
We are looking for a QC professional to support quality testing and compliance activities for our dental medical devices. The role ensures that all materials and finished products meet regulatory and quality requirements as per ISO 13485:2016 and Indian MDR 2017.
Key Responsibilities
- Perform incoming, in-process and finished product testing as per approved test methods and specifications.
- Ensure batch release testing, preparation of COA/COC, and documentation accuracy.
- Handle QC instruments and ensure they are calibrated and qualified (IQ/OQ/PQ).
- Maintain QC documentation in compliance with ISO 13485 and Schedule IV of MDR 2017.
- Support audits, stability studies, validation batches, and non-conformance investigations.
- Manage retention samples, test records, trending sheets, and ensure lab GMP/5S compliance.
Qualifications
- B.Sc / M.Sc in Chemistry, Polymer Science, or related fields.
- 1–5 years of QC experience in medical devices, dental materials, pharmaceutical or polymer-based products.
- Knowledge of ISO 13485, Indian MDR 2017, and laboratory quality systems preferred.
Skills
- Hands-on experience with analytical testing of materials (viscosity, setting time, stability, performance tests).
- Strong documentation and data integrity awareness (ALCOA+).
- Good communication, analytical thinking, and teamwork skills.
5 Days work
Fixed Shift 9:30 am - 6:30 pm
Permanent position.
