Quality Engineer - PMS

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)