5 - 8 years
4 - 7 Lacs
Posted:-1 days ago|
Platform:
Work from Office
Full Time
responsibility of continual improvement and implementation of the organization's Quality Management System
- responsibility for facing 3rd-party regulatory audits, including CE audits (as per EUMDR), ISO 13485 audits, USFDA inspections, customer audits, etc.
- proper conduct and closure of Internal Quality Audits
- Management of customer complaints
- Management of Product-related documentation including Risk Management files, Pre-clinical Test reports, Clinical Evaluation reports, Usability Engineering files
- Conducting required validations, in particular Sterilization Validation, Packaging Validation, Shelf-Life Studies/Stability Studies, Transportation Validation, etc.
Harsoria Healthcare
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