VP, On-Market Quality

Danaher · Sunnyvale, CA +2 more

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QualityFull-time$238k–$327kCompany career page

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Role summary

Vice President of On-Market Quality role at Cepheid (Danaher) overseeing multi-site product performance, quality management systems, and regulatory compliance for in vitro diagnostic products globally. The position provides strategic leadership in complaint handling, field actions, post-market surveillance, and cross-functional collaboration across R&D, manufacturing, and regulatory teams.

What they're looking for

Bachelor's degree in engineering, biology, chemistry, or related field
20+ years in vitro diagnostics, quality engineering, or quality systems in FDA-regulated industry
10+ years leading functions and teams in complex global environments
Deep expertise in FDA Quality System Regulation, ISO 13485, and medical device regulations
Experience leading complaint handling, investigations, field actions, and recalls
Demonstrated ability driving operational improvements via Lean, Six Sigma, or similar methods
Ability to collaborate across executive leadership and cross-functional global teams

What you'll be doing

Lead global strategy and execution for on-market product performance and Quality Management System maintenance across multiple sites
Oversee complaint handling, investigations, field actions, recalls, adverse event reporting, and defect tracking integration
Direct on-market product change management, risk management, and regulatory sustainment under applicable frameworks
Engage and influence R&D, Clinical Affairs, Regulatory, Manufacturing, and Commercial teams on product compliance
Drive labeling and regulatory activities while building and developing high-performing organization through resource planning and employee development

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