Senior Quality Engineer - Complaints Handling
S
Stryker
📍 Gurugram, India, India
Job Description
**What you will do:**
+ Complaint handling and Product investigations of medical devices
+ Perform Visual, functional, dimensional, functional inspection & RCA of field returned products and maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities.
+ Risk management –Risk assessment
+ Review of Process flow, DHR, Inspection plans, Measurement techniques, GRR’s etc; review and analyze Literatures such as Clinical reports, PMCF reports, National register etc. to identify Complaints
+ Create PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis and provide technical guidance and promote quality best practices across the organization.
+ Identify and lead opportunities for process improvement, redesign, and development of workflows.
+ Hold self and others accountable to deliver high quality results with passion, energy and drive to meet business priorities. Mentor, develop and inspire ot...
+ Complaint handling and Product investigations of medical devices
+ Perform Visual, functional, dimensional, functional inspection & RCA of field returned products and maintain and ensure complaint files are complete and accurately reflect corresponding complaint activities.
+ Risk management –Risk assessment
+ Review of Process flow, DHR, Inspection plans, Measurement techniques, GRR’s etc; review and analyze Literatures such as Clinical reports, PMCF reports, National register etc. to identify Complaints
+ Create PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis and provide technical guidance and promote quality best practices across the organization.
+ Identify and lead opportunities for process improvement, redesign, and development of workflows.
+ Hold self and others accountable to deliver high quality results with passion, energy and drive to meet business priorities. Mentor, develop and inspire ot...