Senior Commercial Quality Engineer

Year Thane, Maharashtra, India

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Work with commercial teams to ensure implementation and/or maintenance of QMS that are appropriate for Medical Devices / Life Sciences Manufacturing / Medical Devices Distribution and Services, ISO9001, IVDR and other applicable regulatory and statutory requirements.
Coordinate, plan and manage audits (internal/cross-sites).
Facilitate external audit by certification body and support regulatory inspections by regulatory agencies
Perform internal audits of processes, facilities and documentation to assure compliance with internal procedures and regulatory requirements.
Establish, maintain and update relevant QMS documentation.
Coordinate the Quality Management Review meeting on scheduled basis and prepares metrics and reports.
LMS administrative role for local procedure and practice.
Conduct customer feedback/complaints and trend review, and drive appropriate continual improvement implementation.
Support all Quality compliance and regulatory activities.

Language requirements: Fluent English is mandatory, both spoken and written Fluent of French or Spanish or Italiano is highly preferred

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