Senior Manager, Quality Assurance

Senior Manager, Quality Assurance

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 team as Senior Manager, Quality Assurance.

Job Function:
Quality Management

Location:

Auburn, MA, US, 01501 Work Flexibility:
Onsite (Office/ Production) Pay Range: $115, Job

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 Med Tech company, we ambitiously think in generations instead of quarters to improve patients' lives around the world.

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
• 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

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

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? Apply to be our next Senior Manager, Quality Assurance and help us build the future of Med Tech together.

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…