Quality Engineer - PMS

Job description

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 advantage Applied understanding of GDP, ISO 9001 & ISO 13485 (Good to have). Good understanding of FDA 21CFR Part 822 / 820 (Good to have) Travel Percentage: None