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

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

Harsoria Healthcare

10 - 15 years

15 - 25 Lacs

Gurugram Delhi / NCR

Posted:2 months ago| Platform:

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Skills Required

Overall responsibility for facing 3rd-party regulatory audits customer audits professionals from medical devices industry to head QA function at a fast-growing fully-integrated medical devices manufacturing organization. USFDA inspections etc.

Work Mode

Work from Office

Job Type

Full Time

Job Description

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 Location - Gurgaon (HR) & Baddi (HP) AT LEAST 8 years experience in CE-Certified disposable medical device company depth knowledge of ISO 13485 audits, EUMDR, USFDA inspections, customer audits.

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