Senior Manager, Quality Assurance

KARL STORZ • Auburn, MA

15d • Onsite

About The Position

This role will lead Quality Assurance, Quality Engineering, and Quality Support teams, owning site QMS compliance to FDA, ISO, MDR, CE, and global regulatory standards. The position involves overseeing CAPA, complaints, audits, management review, and quality metrics, and serving as the Site Management Representative for audits and inspections. The Senior Manager will drive continuous improvement through data analytics and quality best practices, while also developing talent, training programs, and fostering a strong quality culture. This is an onsite role at the Auburn, MA office, with an expectation of 5 days per week in the office. The role offers significant ownership, visibility, and influence at the site level, driving meaningful impact on patient safety, customer trust, and global business performance. It involves tackling complex, high-impact challenges and partnering with senior leaders and global teams, shaping decisions with expertise. The position is ideal for someone ready to move beyond compliance and set the standard for quality excellence.

Requirements

• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 501-1,000 employees