The Role
Lead complaint handling and product investigations for medical devices, perform inspections and root-cause analysis, create PMS/PSUR/PMCF and trend reports per EU MDR, manage risk assessments per ISO 14971, review quality documentation, and drive process improvements while mentoring team members.
Summary Generated by Built In
Work Flexibility: Hybrid or Onsite
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.
Skills Required
- B.Tech or M.Tech in Mechanical or Biotechnology
- 5-7 years experience in complaint handling and product investigations
- Hands-on experience with problem-solving methodologies, root cause analysis, 7 QC tools, and CAPA
- Risk management experience as per ISO 14971
- Ability to collaborate and influence within matrix and multi-national teams
- Sound knowledge of medical device complaint handling processes
- Applied understanding of GDP, ISO 9001, ISO 13485
- Understanding of FDA 21 CFR Part 820 and Part 822
- Experience creating PMS plan, PMS report, PSUR, PMCF, and trend/complaint analysis per EU MDR
Inari Medical Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Inari Medical and has not been reviewed or approved by Inari Medical.
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Fair & Transparent Compensation — Pay is considered competitive for many roles, with employees described as 'extremely happy' with total compensation including pay, stock, equity, and benefits. Feedback suggests above‑average salary levels across departments contribute to strong pay sentiment.
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Healthcare Strength — Benefits include comprehensive medical, dental, and vision coverage, with 100% employer‑paid premiums for employees cited in multiple descriptions. Additional options like critical illness, accident, hospital indemnity, and wellness programs reinforce the healthcare offering.
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Leave & Time Off Breadth — Time off is characterized by unlimited PTO, cited as a top benefit by employees. Paid holidays and flexible hours are also referenced, expanding the range of time‑off options.
Inari Medical Insights
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The Company
What We Do
Inari Medical, Inc. is a commercial-stage medical device company focused on developing products to treat and transform the lives of patients suffering from venous diseases.
