● 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, Robust 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)