Associate Director Device Quality Assurance

Role: Associate Director of Device Quality Assurance overseeing device assembly and packaging at the Wilson, NC site, serving as the primary quality and regulatory interface for device operations and design transfer of combination products. Responsibilities include on-site oversight of qualification and validation activities (IQ/OQ/PQ, PPQ), managing deviations, changes, CAPAs, and contributing to risk assessments; ensuring compliance during audits; and fostering cross-functional partnerships with Manufacturing, Validation, and Global QA teams. Qualifications: 5+ years in medical device or combination product QA, with a bachelor's in a relevant scientific discipline; strong technical, problem-solving, communication, and collaboration skills. Preferred: familiarity with design verification, control aspects, and device packaging operations. HighValue: medical devices and combination products, device assembly/packaging, design transfer, validation, deviation management, CAPA, risk assessment, GxP compliance, audits. WorkSetup: onsite with a hybrid model; no travel required.