Senior Manager, Quality Assurance

KARL STORZ North America; Auburn (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

A medical technology company located in Auburn, MA, is seeking an experienced individual to lead Quality Assurance and Engineering teams. This role requires over 10 years of quality experience in the medical device sector, with strong auditing and leadership skills. Responsibilities include owning site compliance with FDA and ISO standards, overseeing quality metrics, and driving continuous improvement initiatives. The role is 100% onsite, allowing impactful contributions to patient safety and team development.

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.

Responsibilities

• Lead Quality Assurance, Quality Engineering, and Quality Support teams.
• Own site QMS compliance to FDA, ISO, and global regulatory standards.
• Oversee CAPA, complaints, audits, management review, and quality metrics.
• Drive continuous improvement through data analytics and quality best practices.

Skills

Quality experience in medical devices

Quality auditing experience

People leadership experience

Communication skills

Analytics skills

Stakeholder management

Education

Bachelor’s degree

Lead Auditor certification (ISO 9001 or 13485)

Job description

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