Senior Manager, Quality Assurance

KARL STORZ SE & Co. KG; Auburn (MA); On-site; USD 180,000 - 210,000; Full time

Benefits offered by this job

Medical, dental, vision

Vacation time

Parental leave

Retirement plan

Wellness program

Job summary

KARL STORZ SE & Co. KG in Auburn, MA is seeking a Senior Manager of Quality Assurance to lead the quality program at the site. The role focuses on ownership of the QMS, CAPA, audits, and driving improvements to ensure patient safety and regulatory compliance.

You will partner with global teams and senior leadership to shape quality strategy and outcomes. The position requires extensive medical device quality experience, leadership capability, and strong analytical skills, with onsite work five

Qualifications

• 10+ years of quality experience in medical devices.
• 7+ years of quality auditing experience.
• 3+ years of people leadership experience.
• 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 management

Quality auditing

People leadership

Regulatory knowledge

Stakeholder management

Communication

Job description

Every day our products and services help to save lives
around the globe. Therefore, we make quality and
reliability our number one priority.

Get to know us and join our teamas

Senior Manager, Quality Assurance

Job Function: Quality Management

Location: Auburn, MA, US, 01501

Work Flexibility: Onsite (Office/ Production)

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, high‑impact 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
• Deep knowledge of FDA 21 CFR 820, ISO 13485, MDR, and risk management
• Strong communication, analytics, and stakeholder‑management 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.

Ready to make an impact?

#LI-NM1

MA Applicants: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

• Medical / Dental / Vision including a state-of-the-art wellness program and access to pet insurance, too!
• 3 weeks vacation accrual for full time roles, paid holidays plus paid sick time too
• Up to 8 weeks of 100% paid company parental leave; includes maternal/ paternal leave, adoption, and fostering of a child.
• 401(k) retirement savings plan providing a match of 66.67% (4%) of the employee’s first 6% contribution (up to IRS limits)
• Section 125 Flexible Spending Accounts
• HSA Savings Accounts with company contribution
• Life, STD & LTD Insurance
• We prepay your tuition up to $5,250 per year! - Tuition pre-imbursement
• Fitness reimbursement of up to $200 annually
• And much more!
• * Field sales, internships, and roles that are regularly scheduled to work less than 30 hours per week are not eligible for vacation, except where required by law.
• Non-employees, including temporary workers and consultants, are not eligible to participate in the KARL STORZ benefits program.
• KARL STORZ reserves the right to change or modify the employee’s job description whether orally or in writing, at any time during the employment relationship. Additionally, KARL STORZ, through its supervisors, may require an employee to perform duties outside their normal description within the sole discretion of the supervisor. Employees must comply will all applicable KARL STORZ policies and procedures.

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 acondition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to askhow credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.