About KARL STORZ
From the operating room to surgery centers-and everywhere in between-KARL STORZ North America is a global leader in medical technology and advanced visualization solutions. We design 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, we ambitiously think in generations instead of quarters to improve patients' lives around the world.
About the 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.
What you'll do
- 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
What you bring
- 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
This role will be onsite at our office in Auburn, MA - expectation is 5 days/ week in the office.
What Will Make You Successful
- Quality & Compliance Leadership: You have deep expertise in medical device quality systems, regulatory requirements, auditing, and CAPA processes, with the ability to drive compliance while advancing continuous improvement initiatives.
- Analytical & Strategic Mindset: You leverage quality, complaint, and service data to identify trends, solve complex problems, mitigate risk, and deliver actionable recommendations that improve customer outcomes and business performance.
- Collaborative Leadership & Influence: You build strong cross-functional relationships, confidently lead teams through audits and quality initiatives, and communicate effectively with employees, leadership, customers, and regulatory agencies.
Why KARL STORZ?
Join KARL STORZ and be part of a team creating medical innovations that truly make a difference. Beyond technology, you'll be part of a culture that values talent as its greatest asset, empowering you to contribute to a mission that improves patient care worldwide.
Ready to make an impact?
Apply to be our next Senior Manager, Quality Assurance and help us build the future of MedTech together.
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