Senior Manager, Quality Assurance

Karl Storz Endoscopy; Auburn (MA); On-site; USD 130,000 - 170,000; Full time

Job summary

KARL STORZ Endoscopy in Auburn, MA is seeking a seasoned Quality leader to own site QMS and regulatory compliance. You will lead Quality Assurance, Engineering, and Support teams, advancing patient safety and business performance.

Ideal candidates bring 10+ years in medical device quality, 7+ years auditing, and 3+ years of leadership, with a Bachelor’s and Lead Auditor cert. This onsite role emphasizes collaboration with senior leaders and global teams.

Qualifications

• 10+ years of quality experience in medical devices.
• 7+ years of quality auditing experience.
• 3+ years of people leadership experience.
• Bachelor's degree and 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.

Responsibilities

• 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.

Skills

Quality leadership

Regulatory knowledge

Data analytics

Stakeholder management

Communication

Education

Bachelor's degree

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, highimpact 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 stakeholdermanagement 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.