Supplier Quality Engineer
Pune, Maharashtra, India
- Understanding the Client Requirements, Conducting the Kickoff call.- Involvement during the planning phase to decide on the scope of the projects and drive through its solutions. - Supporting Mexico, Brazil site for Supplier and Customer Quality area.- Perform Supplier Evaluation and Working to add new suppliers in to Approved Supplier List as per company standard.- Handle Incoming Material Rejections, document the NCs, get RCA & Corrective Actions from Supplier.- Ensuring timely creation of Product Complaints to comply with site’s Internal Metrics, provide Acknowledgment to customers and work with CFT for Investigation of the issue in order to provide 8D report to customer- Working as Administrator for Flex Quality Management System/ FlexQ (company designed QMS to comply with FDA’s 21 CFR regulation for electronic records and signatures).- Maintain Documentation of the manufacturing plant by creating, editing, approving, and rejecting the Project Document as well as QMS documents such as manuals, procedures, forms, and templates in Quality Management System- Provide trainings & QMS tool access to employees (India / Mexico) and assign appropriate roles as per the requirement- Prepare Standard Operating Procedure (SOP), Quality Check List (QCL), FMEA, Control Plan for the processes and maintain its documentation in Document Management System (DMS)