KARL STORZ North America
Vice President, Quality Assurance & Regulatory Affairs
KARL STORZ North America, Auburn, Massachusetts, us, 01501
Overview
Vice President, Quality Assurance & Regulatory Affairs. Hybrid schedule at one of the following offices: El Segundo, CA / Goleta, CA / Auburn, MA / Charlton, MA / Franklin, MA. What you’ll do
Set strategic direction for quality and regulatory operations across North America, harmonizing with global standards. Lead with influence—partner with R&D, Operations, Commercial, and Global teams to ensure quality and compliance at every stage of the product lifecycle. 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 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 MedTech region. For 80 years, we’ve pioneered innovations in minimally invasive surgery and OR integration. With more than 9,000 associates worldwide and 1,800 in the US, we focus on cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes. 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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Vice President, Quality Assurance & Regulatory Affairs. Hybrid schedule at one of the following offices: El Segundo, CA / Goleta, CA / Auburn, MA / Charlton, MA / Franklin, MA. What you’ll do
Set strategic direction for quality and regulatory operations across North America, harmonizing with global standards. Lead with influence—partner with R&D, Operations, Commercial, and Global teams to ensure quality and compliance at every stage of the product lifecycle. 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 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 MedTech region. For 80 years, we’ve pioneered innovations in minimally invasive surgery and OR integration. With more than 9,000 associates worldwide and 1,800 in the US, we focus on cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes. 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.
#J-18808-Ljbffr