Director, Quality Systems

Responsibilities

• Lead and manage the Invisalign Multi-site Quality Management System (QMS) to ensure regulatory compliance and industry best practices.
• Oversee the harmonization of quality system processes, including internal audits, document control, risk management, and corrective actions.
• Partner with the Align Global QMS team to implement corporate policies and drive a single, harmonized global QMS.
• Serve as a technical expert on evolving FDA regulations and international standards, providing guidance to internal stakeholders.
• Interface with regulatory agencies during inspections and premarket submissions.
• Develop and implement quality metrics and KPIs to monitor QMS effectiveness and drive continuous improvement.
• Provide coaching and mentorship to quality staff to build a high-performing team.
• Oversee QMS certification strategy and serve as the primary contact for certification bodies.

Requirements

• Master's degree in Quality Management, Engineering, or a related field (or Bachelor's degree with significant relevant experience).
• Minimum 12 years of experience in the medical device industry.
• At least 8 years of leadership experience within a Quality Systems department.
• Demonstrated expertise in FDA regulations (including QSRs) and ISO 13485.
• Hands-on experience with both Software as a Medical Device (SaMD) and hardware medical devices.
• Lead auditor qualifications.
• Strong analytical, problem-solving, and communication skills.

Preferred Qualifications

• Six Sigma, RAC, or ASQ certifications.
• Proficiency with project management tools and techniques.

Benefits

• Comprehensive medical, dental, and vision insurance.
• 401k plan with company match.
• Employee Stock Purchase Program.
• Paid vacation, sick time, and 11 company-designated holidays.
• Paid parental leave (up to 6 weeks depending on tenure).
• Discounts on Invisalign and Vivera products.

About the Company

Align Technology is a global community of game-changers dedicated to transforming smiles and changing lives. We are a leader in the medical device industry, driven by our core values of agility, customer focus, and accountability.