Senior Manager, Quality Assurance - Auburn, MA
Auburn, MA, US, 01501
This role will be on a hybrid schedule at our office in Auburn, MA - expectation is 3 days/ week in the office.
Why you will love this 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
- 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
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 minimally invasive surgery and OR integration to benefit patients and healthcare providers alike. With more than 9,000 associates worldwide and 1,800 in the US, we pride ourselves on harnessing cutting-edge technology, precise workmanship, and unrivaled customer support to help healthcare facilities manage costs, streamline operations, and deliver positive patient outcomes. With onsite locations and field opportunities across the country, we attract a diverse and talented staff, unified by the desire to foster positive change in the world. Because it’s not just about the tools we create—it’s about the lives we change, together.
#LI-NM1
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 a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member’s base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.
Nearest Major Market: Worcester