Asst. General Manager - Quality

Aussicht: 101

Update Tag: 21-05-2024

Ort: Mumbai Maharashtra

Kategorie: Qualitätssicherung / Qualitätskontrolle

Industrie: Medical Equipment Manufacturing

Position: Mid-Senior level

Jobtyp: Full-time

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Jobinhalt

Roles and Responsibilities :

1) To conduct Vendor Assessment, & Vendor Audit.

2) To conduct Internal Audit, Process Audit in Plants and Manufacturing processes.

3) To do third party calibraton of all Instruments in Quality department as per calibration plan.

4) To conduct third party testing of raw material with defined frequency or as per need basis.

5) To publish Weekly & Monthly MIS for Quality wrt Incoming, In process, Final Supplier Performance & Customer complaint management.

6) To effectively manage customer complaints.

Desired Candidate Profile :

Qualification : B.E / B.Tec ( Electronics & Telecommunication / Mechanical / Electrical )

Experience : 12 - 15 yrs in Medical Device industry

1) Sound knowledge of IVD product license and regulatory activity as per MDR2017, ISO 13485:2019, ISO : 9001:2015

2) Sound knowledge of IVD Instruments and Reagents.

3) Good exposure to Quality Assurance processes wrt Incoming Quality, In process Quality & Final Quality.

4) Good exposure of Quality Assurance of parts like machining, fabrication, molding, electronic components, PCBs, PCs et

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