Director, Medical Device Quality Assurance
Core
Leading the Medical Device Quality Assurance team to oversee Combination Products development for biological therapeutics.
Role type
Director, Medical Device Quality Assurance
Builds
Combination Products development for biological therapeutics
Domain
Biopharmaceuticals / Medical Devices
Required skills
Medical device or combination product industry experience, Regulatory compliance (21CFR Part 4, 820, ISO 13485), Design Controls, QA systems (CAPA, deviations, investigations, change control), Team leadership, Strategic planning
Preferred skills
None stated
Technologies
None stated
Responsibilities
Provide QA oversight of the Medical Device / Combination Products function, Develop strategies to integrate Combination Product development, Create resource plans for QA support, Lead professional development of the QA team, Drive department performance and efficiency, Set department goals aligned with corporate QA objectives, Collaborate with internal and external partners
Seniority
Director, strategic leadership & team management
