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Together with our customers, we're on a mission to make healthcare better.
The Role
Lead complaint handling and product investigations for medical devices, perform inspections and root-cause analysis, create PMS/PSUR reports per EUMDR, conduct risk assessments, review quality documentation, drive process improvements, and mentor 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 of relevant experience
- Hands-on experience in complaint handling and product investigations
- Proficiency with problem-solving methodologies, root cause analysis, and 7 QC tools
- Experience with CAPA and strong analytical ability
- Knowledge of risk management processes 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 and ISO 13485
- Good understanding of FDA 21 CFR Part 822 and 820
- Ability to mentor, lead and develop team members
- Ability to prioritize tasks in a deadline-driven environment
Stryker Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Stryker and has not been reviewed or approved by Stryker.
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Healthcare Strength — Multiple medical plan options with HSA support and global mental‑health access indicate broad, accessible care. These features materially enhance the overall value of the total‑rewards package.
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Retirement Support — A meaningful 401(k) company match with potential additional company contribution, alongside an ESPP, supports long‑term savings and wealth building. Documented plan specifics help employees understand eligibility, timing, and vesting mechanics.
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Parental & Family Support — Paid parental and caregiver leave, adoption and surrogacy assistance, and practical supports like breast milk shipping reflect a comprehensive, family‑friendly approach. These offerings address varied family‑building paths and caregiving needs.
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The Company
What We Do
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at www.stryker.com. Together with our customers, we are driven to make healthcare better.
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