Vice President, Quality Assurance & Regulatory Affairs
Auburn, MA, US, 01501 Charlton, MA, US, 01507 El Segundo, CA, US, 90245
This role will be on a hybrid schedule at one of the following offices : El Segundo, CA / Goleta, CA / Auburn, MA / Charlton, MA / Franklin, MA
Shape the future of quality and regulatory excellence at a global MedTech innovator
Why this role matters:
At KARL STORZ, innovation and precision have defined who we are for more than 80 years. As a privately held, family-owned leader in minimally invasive surgery and operating room integration, we serve healthcare providers worldwide with technologies that improve outcomes and transform patient care. With over 9,500 associates globally, including 2,600 across North America. We are proud to set the standard in craftsmanship, innovation, and customer partnership.
Now, we’re looking for a visionary Vice President of Quality & Regulatory Affairs (North America) to elevate our quality systems, safeguard patient safety, and lead regulatory strategy for one of the most respected names in MedTech. This is a rare opportunity to drive impact across our full value chain, working alongside departments across 6 sites —from R&D through commercialization and post-market—while partnering closely with executive leadership to shape the future of healthcare technology.
The Vice President of Quality & Regulatory Affairs, North America, will oversee the Quality and Regulatory Affairs functions in the North America region and will look to harmonize the North America quality management systems and regulatory processes with the global Quality Management and Patient Health & Regulatory Compliance functions.
What you’ll do:
As the regional head of Quality & Regulatory Affairs, you will:
- Set strategic direction for quality and regulatory operations across North America, harmonizing with global standards.
- Lead with influence—partnering with R&D, Operations, Commercial, and Global teams to ensure quality and compliance at every stage of the product lifecycle.
- Engage with regulators—oversee submissions, inspections, and audits with the FDA and other authorities, ensuring flawless execution.
- Champion continuous improvement, advance risk management, CAPA, and quality system maturity across our manufacturing and distribution sites.
- Inspire leadership—mentor and grow teams, fostering a culture of collaboration, accountability, and operational excellence.
What you bring:
- 15+ years of quality and regulatory affairs experience in the medical device industry, with 10+ years at the senior executive level.
- Bachelor’s degree in life sciences, engineering, or related field (advanced degree preferred).
- Deep knowledge of global regulatory frameworks (FDA QSR, ISO, GMP) and proven track record of leading audits, submissions, and agency interactions.
- Executive presence with the ability to influence in a matrixed, global environment.
- A passion for advancing patient safety through the highest standards of quality.
- Willingness to travel up to 50% (domestic and international).
Why join KARL STORZ:
- Impact with purpose: Every product, process, and decision contribute directly to improving lives.
- Legacy of innovation: Be part of a company with 80+ years of pioneering MedTech solutions.
- Global reach, family values: Experience the scale of a worldwide leader, with the stability and long-term vision of a family-owned enterprise.
- Leadership visibility: Report directly to the North America President, with dotted-line connection to the Global Head of Quality & Regulatory Affairs.
- Career-defining opportunity: Shape the future of quality and regulatory excellence at a company known for its precision, trust, and commitment to patient care.
Who we are:
- KARL STORZ is an independent, family-owned company headquartered in Germany’s renowned MedTech manufacturing region. For 80 years, we’ve pioneered the most groundbreaking innovations in minimally invasive surgery and OR integration to benefit patients and healthcare providers alike. With more than 9,000 associates worldwide and 1,800 in the US, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes. With onsite locations and field opportunities across the country, we attract a diverse and talented staff, unified by the desire to foster positive change in the world. Because it’s not just about the tools we create—it’s about the lives we change, together.
Ready to lead with impact?
Join us in setting the standard for quality and compliance in MedTech. Apply today and help us continue to change lives, together.
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KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member’s base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.
Nearest Major Market: Worcester