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.
• 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, Review NC and CAPA and be able to identify any occurrence of an NC.
• 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 guidelines, Trend report & Complaint analysis.
• 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.
• Other tasks as assigned by manager.

What you need:

Required:

• B. Tech / M.Tech Mechanical, Biotechnology with hands on experience of Complaint handling and product investigations process; problem-solving methodology, root cause analysis, 7 QC tools, Problem Solving & CAPA, Strong Analytical ability, and engineering drawing.
• Hands on experience of Risk Management process as per ISO 14971.
• Experience - 5years -7years
• 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; 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 and mentor and lead a group of individuals towards meeting buisness needs and set them up for future success.