Support the product development projects including phase 3, 4, and 5 quality deliverables
Job Summary
Support the product development projects including phase 3, 4, and 5 quality deliverables.
Leads and implements various product and process improvement methodologies.
Acts as a lead in plant CAPA activities, including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.
Matching Summary
Support the product development projects including phase 3, 4, and 5 quality deliverables.
Salary
Base: $93,225 - $136,730; Bonus/Equity: cash-based incentive program; Benefits: comprehensive benefits package with immediate eligibility including medical, dental, vision, disability, life insurance, and adoption benefits.
Skills & Requirements
Must-have
Quality Management Systems (QMS)
FDA regulations
product and process improvement
risk analysis
test method validations
process validations and capability studies
statistical quality control
Nice-to-have
common set of values
passionately pursuing excellence
reaching for the next great achievement
customer success focus
innovation and collaboration
Key Requirements
Bachelor’s Degree in Engineering or related field
5-7 years’ experience in medical device or regulated manufacturing
Certified Quality Engineering (CQE) or Six Sigma Black Belt desired