Senior Staff Quality Engineer

Stryker · San Jose, CA

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QualityFull-time$133k–$222kCompany career page

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What they're looking for

Bachelor's degree in science, engineering, or related discipline
Minimum 6 years quality and/or R&D experience in medical device industry
Strong knowledge of ISO 13485, GDP, GMP, and medical device regulations
Experience leading root cause investigations, CAPA, and complaint activities
Expertise in nonconformance management and post-market quality initiatives

What you'll be doing

Mentor staff and provide technical direction across multiple quality expertise areas
Lead quality initiatives and projects to enhance performance and customer outcomes
Oversee and approve nonconformance and CAPA activities with expert problem-solving
Manage audit preparation and engagement with regulatory representatives and agencies
Drive continuous improvement by analyzing KPI trends and implementing mitigation strategies

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