Director

• Define, champion, and execute the overarching strategic vision for the Quality Assurance function, ensuring it scales effectively to support the company's expanding product pipeline, development activities, and market objectives.
• Lead, mentor, and develop the Quality Assurance team, fostering a culture of high performance, continuous improvement, and deep regulatory expertise as the company grows.
• Direct the prioritization, delegation, and execution of all Quality Assurance operations, setting clear performance metrics and accountability standards across the function.
• Design, implement, and oversee a statistically and analytically driven Quality Program that proactively measures, monitors, and ensures the attainment of the highest quality standards across the organization.
• Responsible for defining, implementing, and ensuring the consistent quality of a Welldoc’s product development processes and overseeing the entire product lifecycle to meet business and customer expectations through a quality-focused approach.
• Own, strategically enhance, and administer the company's Quality Management System (QMS), ensuring its continued compliance, efficacy, and suitability for the current business scale and future strategic needs.
• Driving continuous improvement initiatives using data from quality metrics, complaint trends, and corrective and preventive actions (CAPAs).
• Establish and lead comprehensive training programs for all relevant staff on critical processes, requirements, quality standards, and procedures.
• Act as the Management Representative for the company's ISO13485-certified environment, responsible for reporting on the performance of the QMS and any need for improvement to executive leadership.
• Collaborate strategically with Product, Regulatory, Clinical, and other departments to architect and implement integrated, company-wide systems and processes that ensure end-to-end product quality and continuous regulatory compliance.
• Participate as a key contributor in operational, financial, and strategic discussions that have a material impact on the entire organization, ensuring quality objectives are factored into all corporate decisions.
• Direct the management and execution of all third-party quality audits, including regulatory inspections.

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