Director, Quality Systems

Role Overview

The Director, Quality Systems is responsible for leading and advancing the company’s Quality Systems strategy, governance, and operational effectiveness to ensure ongoing compliance with global regulatory requirements and industry standards.

What You Will Do

Lead and oversee Quality Systems activities, provide strategic and operational leadership for core Quality Systems processes, drive continuous improvement initiatives, and monitor quality system performance.

Why It Might Be a Fit

This role requires strong leadership, organizational, problem-solving, and decision-making skills, as well as the ability to analyze quality data, trends, and performance indicators to support risk-based decision-making and process improvements.

Requirements

• 10+ years of progressive experience in Quality Assurance, Quality Systems or Quality Compliance within a regulated medical device or life sciences environment
• 5+ years of leadership experience managing direct reports, managers, or cross-functional quality teams
• Strong knowledge of Quality Management Systems (QMS) principles and regulated quality processes
• Deep understanding of applicable regulatory and industry requirements, including FDA 21 CFR Part 820 / Quality System Regulation, FDA 21 CFR Part 803 and 806, ISO 13485, EU MDR, MDSAP, and risk-based quality methodologies

Benefits

• Medical
• Dental
• Vision
• Life/AD&D
• Disability Insurance
• 401(k)
• Vacation
• Sick
• Holiday
• Paid Maternity Leave
• Flexible Spending Accounts
• voluntary Accident
• Critical Illness
• Hospital
• Long-Term Care
• Employee Assistance Program
• Pet Insurance
• on-site Wellness Clinic
• Fitness Center
• Café