Director of Quality and Regulatory

The Director of Quality and Regulatory is responsible for leading DDS Lab’s quality management and regulatory compliance programs across the organization. This role oversees the development, implementation, and continuous improvement of the Quality Management System (QMS) to support compliance with applicable medical device quality and regulatory standards, including ISO 13485, 21 CFR Part 820, and other requirements relevant to DDS Lab’s products and operations. The position drives customer complaint handling, corrective and preventive actions, KPI reporting, controlled documentation, audit readiness, and cross-functional quality initiatives while partnering with operations, sales, finance, product management, and human resources. This leader also supports regulatory submissions and market clearance activities for new products when needed.

Key Responsibilities

• Lead the development, implementation, and continuous improvement of DDS Lab’s Quality Management System to support compliance with applicable quality and regulatory standards.
• Own the customer complaint process, including intake, evaluation, investigation, root cause analysis, corrective actions, and closure of communication with customers.
• Establish, monitor, and report quality KPIs such as remakes, repairs, customer complaints, error tracking, product quality issues, and on-time shipment performance.
• Develop quality improvement goals and facilitate routine quality review meetings to drive accountability and measurable operational improvement.
• Maintain ownership of controlled documents, including quality manuals, procedures, SOPs, work instructions, and training materials, and ensure updates are implemented effectively.
• Partner cross-functionally with Sales, Finance, Product Management, Operations, and Human Resources to identify quality trends, resolve issues, and support process improvements.
• Develop and oversee internal audit and inspection readiness capabilities for key operational areas and support employee retraining as needed to improve quality outcomes.
• Serve as the quality and regulatory liaison for customers, internal stakeholders, and applicable suppliers to ensure requirements are communicated, understood, and implemented.
• Support regulatory strategy and execution for new products, including submissions, registrations, and market clearance activities when applicable.
• Provide leadership, analysis, and reporting that enable data-driven decisions and sustained compliance across DDS Lab operations.

• Bachelor’s degree in a relevant field or equivalent combination of education and experience required.
• Five or more years of leadership experience in quality, regulatory, or operations within a process-driven environment.
• Experience supporting or leading a formal Quality Management System and regulated quality documentation processes.
• Working knowledge of applicable quality and regulatory standards, including ISO 13485 and 21 CFR Part 820, preferred.
• Strong analytical, technical writing, problem-solving, and process improvement skills.
• Ability to lead cross-functional initiatives, communicate effectively with internal and external stakeholders, and drive projects with limited direction.
• Experience developing metrics, dashboards, and presentations to support leadership decision-making preferred.

Special Position Requirements

• Experience in medical device, dental laboratory, manufacturing, or other regulated environments preferred.
• Experience with complaint handling, CAPA, internal audits, and document control strongly preferred.
• Experience supporting regulatory submissions or market clearance activities is a plus.