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.● 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.● Other tasks as assigned by manager.What you need:Required skills:● B. Tech / M.Tech Mechanical, Biotechnology with 2-5 years of work experience. Hands on experience of PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis.● Hands on experience of problem-solving methodology and root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability.● Hands on experience of Risk Management process as per ISO 14971 Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies.● Demonstrated ability to 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.Preferred Skills:Sound knowledge on complaint handling process of medical devices will be an added advantageApplied understanding of GDP, ISO 9001 & ISO 13485 (Good to have).Good understanding of FDA 21CFR Part 822 / 820 (Good to have)

Travel Percentage: None