Senior Manager, Quality Assurance

KARL STORZ; Washington (District of Columbia); On-site; USD 150,000 - 210,000; Full time

Job summary

KARL STORZ is seeking a senior Quality leader to own site QMS compliance and drive patient-safety improvements across global regulatory standards.

Lead QA/Quality Engineering teams, oversee CAPA and audits, and partner with senior leaders to advance continuous improvement while building a strong quality culture. Onsite role based in Auburn, MA with visibility into enterprise quality strategies.

Qualifications

• 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 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 compliance

CAPA

Data analytics

People leadership

Education

Bachelor's degree

Lead Auditor certification (ISO 9001/13485)

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 levelDrive meaningful impact on patient safety, customer trust, and global business performanceTackle complex, high‑impact challenges across CAPA, audits, analytics, and continuous improvementPartner with senior leaders and global teams—your expertise will shape decisionsBuild and inspire a strong Quality team while advancing your own leadership careerIf 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

This role will be onsite at our office in Auburn, MA - expectation is 5 days/ week in the office.

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 stakeholder‑management skills

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.

Ready to make an impact?