Senior Manager, Quality Assurance
KARL STORZ • Auburn, MA69d • Onsite
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Senior Manager, Quality Assurance
KARL STORZ•Auburn, MA
•Onsite
About The Position
KARL STORZ North America is a global leader in medical technology and advanced visualization solutions, designing specialty innovations, smart instruments and devices, integrated ecosystems, and intelligent imaging to build a more connected, software-enabled operating room. As an independent, family-owned MedTech company, KARL STORZ ambitiously thinks in generations instead of quarters to improve patients’ lives around the world. This role offers the opportunity to lead quality with real ownership, visibility, and influence at the site level, driving meaningful impact on patient safety, customer trust, and global business performance. The position involves tackling complex, high-impact challenges across CAPA, audits, analytics, and continuous improvement, partnering with senior leaders and global teams, and building and inspiring a strong Quality team while advancing leadership career. This role is for individuals ready to move beyond compliance and set the standard for quality excellence.
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
Senior
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