Sr. Manager, Quality Engineering
$164.6k - $263.4kBecton Dickinson & Co
Senior Manager overseeing failure analysis investigations and root cause analysis for medical device products. Leads engineering teams to identify product failures, implement corrective actions, and drive quality improvements across cross-functional initiatives.
Responsibilities
- Manage failure analysis investigations to identify root causes and implement corrective actions
- Lead cross-functional teams using Six Sigma and Lean methodologies to improve product reliability
- Develop and oversee robust failure analysis tools and processes for proactive quality improvements
- Direct team members with hire/fire authority and provide coaching on performance and development
- Lead CAPA program implementation including training, approvals, and system effectiveness monitoring
Requirements
- Bachelor's degree in engineering
- 8+ years medical device failure analysis and quality engineering experience
- Six Sigma certification
- Demonstrated technical team management and project leadership experience
- Expert knowledge of FDA regulations, GMPs, and ISO/EN standards
- Proficiency in design of experiments, FMEA, and statistical process control
- Strong problem-solving, analytical, and critical thinking abilities
$164.6k - $263.4k
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