• Oversee the quality and compliance of combination products, ensuring they meet regulatory standards and company objectives. • Develop and implement quality strategies and processes for combination products, in alignment with company goals and regulatory requirements. • Act as the QA contact for all quality-related inquiries and issues concerning device and combination products. • Collaborate with cross-functional teams, including product development, manufacturing, clinical development, supply chain, commercial, quality, and regulatory affairs, to ensure quality and compliance throughout the combination product lifecycle. • Help define and implement as appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations. • Stay up-to-date with changes in medical device and combination product regulations and industry best practices. • Participate in the development, review and approval of product documentation, including design control, risk management, and validation. • Identify gaps and improvement opportunities within the Design History File and Risk Management and track to closure. • Collaborate with external partners and suppliers to ensure quality and compliance with company standards. Perform quality assurance oversight for validation studies conducted by external partners. • Communicate effectively with senior management to provide updates on the status of quality and compliance for medical device / combination product. • Participate in preparation for and execution of regulatory audits. Ensures audit observations related to functional area are addressed appropriately and completed on schedule. • Act as the Quality representative on assigned product teams to advocate compliance and quality assurance. • Availability for 5-15% travel, both domestically and internationally.