About KARL STORZ

From the operating room to clinics—and everywhere in between—KARL STORZ North America (KSNA) is a global leader in medical technology and advanced visualization solutions. We design innovative systems that empower physicians to make informed clinical decisions and improve patient outcomes worldwide.

As a family-owned company with over 80 years of innovation, we are driven by precision, performance, and purpose. With more than 8,500 employees globally and 2,400 in the North America, our impact extends far beyond devices—it’s about advancing care and changing lives.

About the Role

As Senior Manager, Quality Assurance, you will own and shape the quality function at the site level, driving excellence across Quality Assurance, Engineering, and Support. You’ll move beyond compliance to build a high-performing quality organization that directly impacts patient safety, regulatory success, and business performance.

You’ll partner with senior leaders, influence global strategy, and lead through complexity—bringing clarity, accountability, and continuous improvement to every aspect of the Quality Management System.

If you’re ready to set the standard—not just meet it—this role is built for you.

Why You’ll Love This Role

• Directly impact patient safety, product quality, and customer trust
• Lead quality where it matters most—with ownership and visibility at the site level
• Solve complex, high-stakes challenges across CAPA, audits, and continuous improvement
• Partner with executive leadership and global stakeholders—your voice will shape decisions
• Build, mentor, and elevate a high-performing Quality team
• Step into a role that accelerates your leadership trajectory

What You’ll Do

Quality Leadership & Strategy

• Lead Quality Assurance, Quality Engineering, and Quality Support functions
• Establish and execute site-level quality strategy aligned with global objectives
• Serve as the site’s primary Quality leader and escalation point

Regulatory & QMS Ownership

• Own compliance with FDA, ISO 13485, MDR, CE, and global regulatory standards
• Act as Site Management Representative during audits and inspections
• Ensure a robust, inspection-ready Quality Management System

 Operational Excellence

• Oversee CAPA, complaint handling, audits, management reviews, and quality metrics
• Leverage data analytics to identify trends, mitigate risk, and drive decisions
• Champion continuous improvement initiatives across the site

Talent & Culture Development

• Build and develop a high-performing, engaged Quality team
• Implement training programs that strengthen capability and compliance
• Foster a culture of accountability, quality ownership, and continuous improvement

What You Bring

Experience & Expertise

• 10+ years of quality experience in the medical device industry
• 7+ years of auditing experience (internal, external, or supplier)
• 3+ years of people leadership with a track record of team development

Technical Knowledge

• Deep expertise in FDA 21 CFR 820, ISO 13485, MDR, and risk management
• Strong understanding of QMS processes, CAPA systems, and audit readiness
• Lead Auditor certification (ISO 9001 or ISO 13485) preferred

Leadership & Impact

• Proven ability to influence cross-functional and senior stakeholders
• Strong analytical mindset with the ability to translate data into action
• Exceptional communication skills—clear, concise, and credible

Education

• Bachelor’s degree required (engineering or related field preferred)

Who You Are

You’re a builder and a leader. You see quality not as a checkpoint, but as a competitive advantage. You thrive in complex, regulated environments and bring structure where others see ambiguity.

You challenge the status quo, develop people around you, and lead with both accountability and purpose. Most importantly, you understand that behind every process, product, and audit is a patient counting on you.

Why KARL STORZ?

At KARL STORZ, your work has real impact. You won’t just ensure compliance—you’ll help define what quality excellence looks like in a global MedTech organization.

If you’re ready to lead with purpose and elevate quality to its highest standard, we’d love to connect.

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