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Lead Engineering Verification and Validation Activities managing a small contingent of validation engineers.Serve as Subject Matter Expert (SME) for all verification and validation activities.Devel... Show more
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Position: Validation Manager
Location: Hercules, CA
Duration: Full time
Lead Engineering Verification and Validation Activities managing a small contingent of validation engineers.
Serve as Subject Matter Expert (SME) for all verification and validation activities
Develop and oversee verification protocols to verify engineering specifications
Develop and oversee validation protocols to validate customer requirements
Analyze verification and validation test data
Document test protocols and reports
Support Root Cause Analyses and Develop Corrective Measures
o Conduct root cause analysis using test data and/or field failure data
o Develop and verify/validate effective countermeasures against root cause(s) of failure
Support Reliability Improvement Projects
o Apply methodologies to drive reliability improvements
o Develop and execute reliability test methods
Support Change Control Process
Support Engineering Design Reviews
Required Skills
An understanding/working knowledge of Fluidics/Filling Operations, Automation, Robotics, Cold Storage, Packaging, and site validation. DI Water Systems
Highly proficient in the use of MS Office Suite (Word, Excel, Power-point, Project)
Proficient in the use of Minitab and/or other statistical analysis software
Excellent written and verbal communication skills
Ability to work effectively in teams cross-functionally and within engineering
Ability to multitask effectively and efficiently
Ability to work effectively with general direction
Highly capable of independent and critical thought and action
Required Experience
BS/MS in an Engineering discipline or Physical Sciences
Six Sigma Green Belt (preferred)
Test Implementation, Verification & Validation, and Risk Assessment
Root Cause Analysis, Development of Corrective Actions
Hands on application of Statistical Analysis
Working knowledge of FDA regulatory requirements and all internal quality standards
5-7 years of experience in medical device validation/FDA regulated industry.
3-5 years of management leadership experience
Project planning skills
Qualifications
BS/MS in an Engineering discipline or Physical Sciences
