Senior Quality Engineer - Complaints Handling

Work Flexibility: Hybrid or Onsite **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 others in current and future roles. **What you need:** Required: * B. Tech / M.Tech Mechanical, Biotechnology * Experience - 5 years -7 years * Hands on experience of Complaint handling and product investigations process. Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability and Risk Management process as per ISO 14971. * Sound knowledge on complaint handling process of medical devices will be an added advantage. * Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have).Good understanding of FDA 21CFR Part 822 / 820 (Good to have). * Ability to collaborate and influence within matrix organizations and engage effectively with multiple stakeholders across multi-national teams. Preferred: * Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies; self-motivate, ability to prioritize tasks in a deadline-driven environment. * Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams and to mentor and lead a group of individuals towards meeting business needs and set them up for future success. Travel Percentage: 20%