Director, Quality Systems

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. 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%