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Job Description
- Req#: R512365
- To review and prepare QMS documents - procedures, work instructions, forms and/ or policies related to different QMS activities through the Change Control process.
- To coordinate with process owners from different functional departments for executing Change Control and organize Change Control Board (CCB) meetings.
- Execute the Change Control process in the Windchill system (onePLM).
- Archival of QMS documents at Shared Folder and to update Master List of Documents.
- To review changes in Corporate documents through the Change Implementation Decision Task process (CIDT) in onePLM.
- To coordinate with GPO for clarification and understanding of corporate changes.
- To implement the changes in local QMS documents through the Change Control process.
- Responsible for submitting the CIDT dispositions in onePLM.
- To update and maintain the training Plan.
- Assign trainings of QMS documents in Compliance Wire (SLMS).
- Review and Approval of RAQA assessment of IC in IC Hub.
- Prepare and share inspection report after inspection of PRI/ Damaged shipment/ Consignment Return/ MOVEIT shipments.
- Coordination with CE and warehouse for missing approvals and PRI details.
- Update and maintain relevant trackers.
- Update Label Master for requested items.
- Review Label Master quarterly and maintain archival at SharePoint.
- Coordination with Warehouse, RA & Pricing Finance team for MRP Label size, Licence details and MRP.
- Responsible to handle site Non-conformance and CAPA process through TrackWise.
- Responsible for tracking of Action Plans of Management Review Meeting. Support in Internal Audit Process
Work Flexibility: OnsiteResponsible for managing the Change Control process: -
Responsible for managing the CIDT and Manage release received from corporate:
Responsible for management of QMS Training program in SIPL :-
Responsible for handling ICM - RAQA Assessment: -
Support in Inspection of Products Return Inspection/ PDI/ Damage shipment/ Consignment Return
Responsible for handling and updating Indian Specific Label Master
About the company
Stryker Corporation is an American multinational medical technologies firm based in Kalamazoo, Michigan.
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