Director, Quality Systems

Director, Quality Systems

Department: Quality

Employment Type: Full Time

Location: US-North Carolina-Raleigh

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%

• Master's degree in Quality Management, Engineering, or a related field, or Bachelor's 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

If provided, base salary or wage rate ranges are the range in which Align reasonably expects to set a candidate’s pay for the posted position. Actual placement depends on the individual skills and experience level of a candidate plus the total compensation and equity across team members. For other locations outside of the primary location, the base salary range will be adjusted geographically.

For…