Quality Assurance Manager

The candidate should have fair knowledge of MDR and US FDA or Ce certification process flow.

Job Description:

• Responsible to monitor and ensure that the Quality Management System (QMS) is implemented. The person needs to ensure all Validation & Qualification process is in right order.
• Responsible for establishing Quality System processes with an aim to receive FDA, ISO 13485 accreditation, GMP, CE certification or any other certification as required.
• Responsible to conduct and coordinate Internal Audits, Management Review Meetings as per the defined policies and procedures.
• Responsible for preparation, amendment, distribution, retrieval and destruction of quality system & technical documents.
• Responsible for inspecting, approving and rejecting the quality of raw materials, in process and finished products. Responsible for final batch release.
• Responsible for final disposition of all non-conformities identified during incoming, in process and final processes.
• Responsible for handling queries related to complaints of the customer.
• Responsible for identification, maintenance & calibration of inspection measuring & monitoring equipment.