Required Quality Assurance(QA) professional from medical devices Ind.

JOB 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. To work as PRRC (Person responsible for regulatory compliance as per EUMDR.

4. Leading proper conduct and closure of Internal Quality Audits

5. Management of customer complaints & CAPA.

6. Management of Product-related documentation including Risk Management files, Pre-clinical Test reports, Clinical Evaluation reports, Usability Engineering files

7. 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 8 years experience in CE-Certified disposable medical device company

depth knowledge of ISO 13485 audits, EUMDR, USFDA inspections, customer audits.