Senior Manager, Quality Assurance

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

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

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

Qualifications

• Experience in medical device quality systems, regulatory requirements, auditing, and CAPA processes
• Ability to drive compliance while advancing continuous improvement initiatives
• Leverage quality, complaint, and service data to identify trends, solve complex problems, mitigate risk, and deliver actionable recommendations
• Build strong cross-functional relationships, confidently lead teams through audits and quality initiatives, and communicate effectively with employees, leadership, customers, and regulatory agencies

Skills

• Quality & Compliance Leadership
• Analytical & Strategic Mindset
• Collaborative Leadership & Influence

Pay

$100,000 - $120,000 annually

Schedule

Full-time, 5 days/week

Benefits

Comprehensive benefits package including health insurance, retirement plans, and paid time off

Location

Auburn, MA