Director, Quality Systems

Company: Align Technology, Inc.
Location: Raleigh
Posted on: March 20, 2026

Job Description:

We are seeking a dynamic and experienced Director, Quality Systems to lead the Invisalign QMS. The successful candidate will partner with Align Global QMS leaders to create a quality management infrastructure that is compliant, effective, efficient, agile, and that supports a rapidly growing business with complex and diverse product lines (both hardware and software). S/he will play a crucial role in maintaining and enhancing our Quality Management System (QMS) to ensure compliance with all relevant regulations and standards, including FDA QMSR, ISO 13485, and other applicable international guidelines. S/he will partner with cross-functional teams across the organization to champion a culture of quality excellence, continuously improving our processes and procedures to guarantee patient safety and product effectiveness. Role expectations • Lead and manage the Invisalign Multi-site QMS to ensure industry best practices and compliance with regulatory requirements. • Oversee the harmonization of quality system processes at various global sites included in the scope of the Invisalign quality system including internal audits, document control, risk management, non-conformance and corrective action handling, inspections, training, and management review • Partner closely with the Align Global QMS team to implement corporate QMS policies and work towards a single, harmonized, global QMS for Align. • Serve as a technical expert in QMS best practices staying abreast of evolving FDA regulations and international standards, providing guidance and interpretation to internal stakeholders. • Interface with regulatory agencies during inspections and premarket submissions, ensuring clear and timely communication on all quality-related matters. • Foster a culture of quality consciousness throughout the organization, promoting awareness of regulatory requirements and best practices across all departments. • Develop and implement quality metrics and key performance indicators (KPIs) to monitor the effectiveness of the QMS and identify areas for improvement. • Lead and participate in various quality projects and initiatives, driving continuous improvement efforts within the organization. • Provide coaching and mentorship to quality staff, building and developing a high-performing team. • Oversee QMS certification strategy for various Align locations and legal manufacturers • Be single point of contact for communication with QMS certification bodies • Effectively develop and deliver updates to executive management on a regular basis • Possible travel 15% What were looking for • Masters degree in Quality Management, Engineering, or a related field, or Bachelors degree with significant experience in a quality-related role. • Minimum 12 years of experience in the medical device industry, with at least 8 years in a leadership position within a Quality Systems department. • Demonstrated expertise in FDA regulations, including QSRs, and relevant international standards, such as ISO 13485. • Expert understanding of Quality Management System principles and implementation methodologies. • Proven ability to build and lead high-performing teams, fostering a collaborative and proactive work environment. • Excellent communication, interpersonal, and presentation skills. • Meticulous attention to detail and ability to manage multiple priorities effectively. • Strong analytical and problem-solving skills with a data-driven approach to quality improvement. • Hands on experience with both SaMD and hardware medical devices • A working knowledge of project management tools and techniques is required. • Six Sigma, RAC, ASQ certification is preferred. • Lead auditor qualifications

Keywords: Align Technology, Inc., Winston-Salem , Director, Quality Systems, Engineering , Raleigh, North Carolina