Work Flexibility: Hybrid or Onsite

What you will do:

Complaint handling and Product investigations of medical devicesPerform 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 assessmentReview 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 ComplaintsCreate PMS plan, PMS report, PSUR report as per EUMDR, Trend report & Complaint analysis.Other tasks as assigned by manager.

What you need:

Required:

B. Tech / M.Tech Mechanical, Biotechnology with 4-7 years of work experienceHands 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.Hands on experience of Risk Management process as per ISO 14971Sound 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)

Preferred:

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.

Travel Percentage: 20%