About the Role
JOB DESCRIPTION Coordinate and plan supplier audits in conjunction with the global supplier quality, Quality Manager, procurement team, RD&E and Internal stakeholders. Conduct ISO9001 and ISO13485 (including any applicable specific requirements) audits for suppliers based on the plan / business urgency. Communication with suppliers on action plan preparation/review. Follow-up to the action plans resulting from these audits. Lead or support root cause investigation of nonconformities and develop, initiate, or implement corrective actions. Conduct periodic review and analysis supplier actions using quality tools including, but not limited to: FMEA, DFMEA, PFMEA, DQ, IQ, OQ, PQ, control plans, process verification/validation plans, equipment qualification, PDA, Cpk, SPC, statistical process control and DMAIC. Develop, implement, and ensure that the supplier conforms to customer, internal, regulatory/lega...
DUTIES AND RESPONSIBILITIES:
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