Senior Quality Engineer - Complaints Handling
Stryker · Gurugram, India
QualityFull-timeCompany career page
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Role summary
Stryker seeks a Senior Quality Engineer to manage complaint handling and investigations for medical devices in a hybrid Gurugram role. The position involves conducting product inspections, root cause analysis, risk assessments, and regulatory compliance activities while mentoring quality teams.
What they're looking for
- B.Tech or M.Tech in Mechanical or Biotechnology with 5-7 years complaint handling experience
- Proficiency in root cause analysis, 7 QC tools, CAPA, and problem-solving methodologies
- Hands-on experience with ISO 14971 risk management processes
- Strong analytical skills and ability to interpret engineering drawings
- Knowledge of ISO 9001, ISO 13485, and FDA 21CFR Part 822/820 regulations
- Demonstrated cross-functional collaboration and stakeholder engagement capabilities
What you'll be doing
- Execute complaint handling and product investigation activities for returned medical devices
- Perform visual, functional, and dimensional inspections with root cause analysis on field returns
- Review and maintain complete complaint documentation, DHR files, and inspection plans
- Develop regulatory reports including PMS plans, PSUR, and trend analyses per EUMDR guidelines
- Lead process improvement initiatives and mentor team members on quality best practices
Privacy & handoff
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