QA-Head Required For disposable Medical Devices Mfg Plant

Role & responsibilities

1. Overall responsibility of continual improvement and implementation of the organization's Quality Management System
2. - Overall responsibility for facing 3rd-party regulatory audits, including CE audits (as per EUMDR), ISO 13485 audits, USFDA inspections, customer audits, etc.
3. - Leading proper conduct and closure of Internal Quality Audits
4. - Management of customer complaints & CAPA.
5. - Management of Product-related documentation including Risk Management files, Pre-clinical Test reports, Clinical Evaluation reports, Usability Engineering files
6. - Conducting required validations, in particular Sterilization Validation, Packaging Validation, Shelf-Life Studies/Stability Studies, Transportation Validation, etc.

Preferred candidate profile -

• ISO 13485 lead auditor training
• at least 12 yrs experience in Medical Device
• depth knowledge of ISO 13485, EUMDR regulations, 21 CFR (USFDA) regulations
• Candidate from Delhi-NCR location or willing to re-locate to Gurgaon-HR