Base: $85,000.00 to $95,000.00; bonus/equity: not ...
On-site
Perform trend analyses on quality data
Develop and implement value improvement projects
Perform internal quality audits
ZOLL is seeking a Quality Assurance Engineer to enhance its Acute Care Technology division, which develops life-saving medical devices and software. The ideal candidate will have experience in FDA-regulated environments and be skilled in quality assurance processes, with a focus on Lean and Six Sigma methodologies
Job Summary
Performs a variety of complex tasks related to Quality Assurance including, but not limited to: performing trend analyses on quality data to provide early warning of potential problems and improvement opportunities.
Responsible for the development and execution of Lean/six-Sigma and other cost improvement initiatives that can be related to product quality.
Participates in the FDA premarket approval process (PMA) for new and modified medical devices.
Matching Summary
Match Score: 85
ZOLL is seeking a Quality Assurance Engineer to enhance its Acute Care Technology division, which develops life-saving medical devices and software. The ideal candidate will have experience in FDA-regulated environments and be skilled in quality assurance processes, with a focus on Lean and Six Sigma methodologies.
Salary
Base: $85,000.00 to $95,000.00; Bonus/Equity: Not specified; Benefits: Comprehensive benefits plans
Skills & Requirements
Must-have
perform trend analyses on quality data
develop and implement value improvement projects
perform internal quality audits
conduct supplier evaluations and audits
understand legal and regulatory requirements
ensure operations quality measurement systems are capable
conduct risk analysis activities
prepare and submit process validation requirements
Nice-to-have
improve key business relationships
champion Lean Manufacturing processes
participate in Kaizen events
Key Requirements
BS degree or equivalent experience
FDA regulated Class III electrical medical device manufacturing environment experience
process development and validation for electro-mechanical assembly, test, and service experience
Formal Project management experience
Lean experience
database queries and reporting in SQL or Microsoft Access experience