Senior Quality Engineer - Complaints Handling

• 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:

• B. Tech / M.Tech Mechanical, Biotechnology with 4-7 years of work experience
• 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.
• Hands on experience of 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)

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.