Manager, Quality Assurance at KARL STORZ Endoscopy - America

Join Our Team at KARL STORZ U.S. – Elevate Quality and Drive Continuous Improvement

Are you passionate about quality and regulatory compliance in the medical device industry? Do you thrive in a leadership role, guiding teams to achieve excellence? If so, we want you to join our team as a Quality Assurance Manager at KARL STORZ, a global leader in endoscopy, medical device technology, and healthcare solutions.

Why KARL STORZ?

• Be Part of Innovation: Drive continuous improvement and contribute to products that impact healthcare worldwide.
• Leadership Impact: Lead and develop a talented team, influencing quality initiatives and shaping the future of medical technology.
• Career Growth: With our commitment to ongoing learning, you’ll have ample opportunities to advance and expand your skill set in a dynamic environment.

What you will be doing:

• Quality System Oversight: Ensure compliance with FDA, ISO, EN, and MDR standards, leading audits, CAPA processes, and driving quality improvement initiatives.
• Data Analytics: Analyze field failure data to identify trends, make recommendations for design or process improvements, and reduce costs and service impact.
• Audits & Compliance: Host and manage internal and external audits, ensuring quality system adherence across global operations.
• Leadership & Mentoring: Lead a team, provide training, and foster a collaborative, high-performance culture. Drive continuous improvement across the quality system.
• Cross-Functional Collaboration: Work closely with departments like engineering, production, and customer service to resolve issues and improve quality and compliance.

What you will need to be considered:

• Experience: 7+ years in quality management roles within the medical device industry; 3-5 years in quality auditing.
• Education: Bachelor’s degree in a relevant field.
• Certifications: Lead Auditor training for ISO 9001/ISO 13485, CQE or CQM certifications preferred.
• Skills: Strong knowledge of FDA regulations, ISO standards (13485, 14971), and experience with ERP systems like SAP. Proficiency in Microsoft Office tools.
• Leadership: Proven ability to lead and mentor teams, delivering high-quality results and driving cross-functional collaboration.

What’s in it for you?

• Competitive Compensation: Attractive salary and benefits, including healthcare, retirement plan, and more.
• Career Advancement: Access to ongoing training, leadership development, and internal growth opportunities.
• Work-Life Balance: Flexible work environment with minimal travel required (up to 20%).
• Impactful Role: Make a tangible difference in the quality of healthcare products, ensuring they meet the highest standards.

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 endoscopic surgery, video imaging, and OR integration to benefit patients and healthcare providers alike. 

With a 9000+ employees worldwide, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support. In doing so, we help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes.

Ready to make an impact? Apply today and help us shape the future of medical technology at KARL STORZ.

#LI-BL1