Staff Quality Engineer, NPI

Stryker-posted about 17 hours ago
Full-time • Mid Level
Onsite • San Jose, CA
5,001-10,000 employees
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As a Staff NPI Quality Engineer , you will provide quality assurance support for all aspects of New Product Introductions (NPI), ensuring compliance with domestic and international regulations while driving product competitiveness. This role focuses on Design Control, Process Validation, Supplier Quality, Risk Management, and NC/CAPA throughout the product lifecycle.

  • Drive quality strategies for inspection, testing, and supplier qualification during new product development.
  • Ensure proper linkage between design inputs/outputs, process controls, and customer needs during design transfer.
  • Develop inspection documents, validate test methods, and implement inspection strategies for NPI projects.
  • Lead or support process validation activities (IQ/OQ/PQ), including protocol development and execution.
  • Identify, audit, and onboard new suppliers, lead component and product qualification activities.
  • Create and maintain process risk documentation per ISO 14971 for regulatory submissions.
  • Investigate and close non-conformances and CAPAs related to new product development.
  • Support creation of Device Master Records and training during production process transfer.
  • Collaborate with cross-functional teams to ensure compliance with ISO 13485, FDA regulations, and internal quality systems.
  • Promote a customer-centric quality culture and support internal/external audits.
  • Bachelor’s degree in engineering or related field.
  • 5+ years of experience in Quality Engineering within medical device or regulated industry.
  • Strong knowledge of Design Control, Process Validation, Risk Management, and Supplier Quality.
  • Familiarity with ISO 13485, ISO 14971, and FDA regulations.
  • Excellent communication and leadership skills; ability to train and influence cross-functional teams.
  • Master’s degree in relevant field desired.
  • ASQ-CQE, CQA or equivalent course work/experience desired.
  • Experience with electrical/electro-mechanical systems, electrical V&V (IEC 60601, EMC/EMI), automated test equipment (LabVIEW/TestStand), electrical DFMEA/PFMEA, PCBA supplier qualification, and relevant certifications.
  • Experience with statistical rationale for validation, sterilization validation strategies, and post-launch monitoring.
  • Advanced understanding of inspection strategies and test method validation
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