Medical Device Quality Manager

Role: Lead Quality Assurance for combination products and medical devices, ensuring compliance and on-time product delivery across AbbVie's portfolio including implants, ocular devices, dermal fillers, infusion pumps, and enteral tubing. Responsibilities: develop and implement global quality strategies, oversee quality metrics, manage cross-functional teams and external partners, lead product transfer and on-market support initiatives, coordinate audits and inspections, and investigate quality issues. Collaborates with Regulatory Affairs to align regulatory strategies. Requirements: Bachelor's in Life Sciences or technical field; 7+ years in QA operations, regulatory, or technical support; strong background in quality control, manufacturing, and validation, with experience in third-party manufacturing. Preferred: advanced degree, leadership experience in biopharma or medtech, familiarity with GxP, and regulatory audit processes. High-Value: focus on combination products and medical devices, regulatory compliance, product lifecycle support, and cross-functional stakeholder engagement. Work setup: not specified; international scope implies potential for global collaboration.