- Location
- Haryana, Gurugram International Techpark, Block I Phase 1 Floors G, 3, 4, 5, India
- Workplace
- Hybrid
- Type
- Full-time
- Department
- Engineering
- Seniority
- Senior
- Source
- Workday
Description
Work Flexibility: Hybrid
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.
Skills
FDARisk Management