Senior Quality Engineer - Complaints Handling

What you will do:

• Complaint handling and Product investigations of medical devices
• Perform Visual, functional, dimensional, functional inspection & RCA of field returned products and 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 and provide technical guidance and promote quality best practices across the organization.
• Identify and lead opportunities for process improvement, redesign, and development of workflows.
• Hold self and others accountable to deliver high quality results with passion, energy and drive to meet business priorities. Mentor, develop and inspire others in current and future roles.

What you need:

Required:

• B. Tech / M.Tech Mechanical, Biotechnology
• Experience - 5 years -7 years
• 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 and 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).
• Ability to collaborate and influence within matrix organizations and engage effectively with multiple stakeholders across multi-national teams.

Preferred:

• Demonstrated ability to work effectively with various work groups to assure conformance to regulatory requirements, internal processes, and policies; 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 and to mentor and lead a group of individuals towards meeting business needs and set them up for future success.