Senior Quality Assurance Manager - Surgical Support & Post Market

Stryker · San Jose, CA

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QualityFull-time$176k–$294kCompany career page

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What they're looking for

Bachelor's degree in Engineering, Science, or related technical discipline
10+ years experience in regulated manufacturing (medical device, pharmaceutical, biomedical, automotive)
4+ years leading teams with development, performance management, talent acquisition responsibilities
Product lifecycle quality experience including post-market, customer, engineering, manufacturing quality
Proficiency with quality tools: Root Cause Analysis, FMEA, SPC, CAPA, Six Sigma
FDA compliance and quality systems regulatory experience including audits and inspections
Cross-functional quality initiative leadership across multiple functions, products, or sites

What you'll be doing

Lead quality assurance for legacy surgical device portfolios through product development and post-market lifecycle
Define quality strategy with cross-functional leaders, establish performance metrics, drive continuous improvement
Direct post-market surveillance initiatives using data-driven insights for risk mitigation and business decisions
Monitor product quality trends and communicate findings to senior leadership for proactive action
Chair quality review boards, oversee engineering changes, ensure risk analysis and verification execution

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