Senior Manager, Quality Assurance - Auburn, MA
About The Position
This role will be on a hybrid schedule at our office in Auburn, MA - expectation is 3 days/ week in the office. Why you will love this role: Lead quality where it matters most—with real ownership, visibility, and influence at the site level Drive meaningful impact on patient safety, customer trust, and global business performance Tackle complex, high‑impact challenges across CAPA, audits, analytics, and continuous improvement Partner with senior leaders and global teams—your expertise will shape decisions Build and inspire a strong Quality team while advancing your own leadership career If you’re ready to move beyond compliance and set the standard for quality excellence, this role is built for you.
Requirements
- 10+ years of quality experience in medical devices
- 7+ years of quality auditing experience
- 3+ years of people leadership experience
- Bachelor’s degree; Lead Auditor certification (ISO 9001 or 13485)
- Deep knowledge of FDA 21 CFR 820, ISO 13485, MDR, and risk management
- Strong communication, analytics, and stakeholder‑management skills
Responsibilities
- Lead Quality Assurance, Quality Engineering, and Quality Support teams
- Own site QMS compliance to FDA, ISO, MDR, CE, and global regulatory standards
- Oversee CAPA, complaints, audits, management review, and quality metrics
- Serve as Site Management Representative for audits and inspections
- Drive continuous improvement through data analytics and quality best practices
- Develop talent, training programs, and a strong quality culture
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
501-1,000 employees
