Senior Manager, Quality Assurance

Job description

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. #LI-NM1