This role serves as the cornerstone of quality assurance for designated product lines, owning everything from product design manufacturability to supplier partnerships
Job Summary
This role serves as the cornerstone of quality assurance for designated product lines, owning everything from product design manufacturability to supplier partnerships.
The position requires maintaining FDA and ISO regulatory compliance while leading internal and external audits to ensure processes exceed industry standards.
Candidates will drive continuous improvement by analyzing quality indicators, managing CAPAs, and supporting the coordinated launch of new products into manufacturing.
Matching Summary
This role serves as the cornerstone of quality assurance for designated product lines, owning everything from product design manufacturability to supplier partnerships.
Salary
Base: $95,900.00 - $153,400.00 USD Annual; Bonus/Equity: Not specified; Benefits: Comprehensive Total Rewards program including performance-based culture
Skills & Requirements
Must-have
BS degree in Engineering or related field
3 years Quality Operations experience
Medical device industry background
Electro-mechanical instrument systems knowledge
FDA and ISO regulatory compliance expertise
Nice-to-have
Minitab statistical analysis proficiency
Six Sigma certification preferred
Certified Quality Auditor credential
Experience with Design History Files
Strong cross-functional collaboration skills
Key Requirements
Minimum 3 years Quality Operations in medical device
Bachelor's degree in Electrical, Mechanical, or Industrial Engineering
Proficiency with Microsoft Office suite
Ability to handle multiple projects in fast-paced environment