Associate Director, Design Quality – Design Lifecycle Management
Core
Oversees the Design Lifecycle Management team for combination products and medical devices, managing design transfer to manufacturing and lifecycle change management.
Role type
Senior leadership quality operations manager (medical devices/pharma)
Builds
Seamless design transfer of new products into manufacturing and lifecycle management for on-market products
Domain
Medical devices and pharmaceuticals
Deliverable
client delivery
Required skills
Quality Assurance Operations Management, Regulatory inspection experience, Plant experience, Problem resolution, Strategic decision making, Cross-functional collaboration, Risk management, Continuous improvement, Third-party manufacturing oversight
Preferred skills
Graduate degree, Biological/pharmaceutical technology knowledge, Direct Plant experience (5+ years)
Technologies
Design History Files, Risk management processes, Validation tools
Responsibilities
Lead and develop a team of quality professionals and SMEs, Oversee execution of quality requirements for lifecycle management, Facilitate Change Control activities and impact assessments, Develop design control strategies with cross-functional teams, Collect and analyze quality metrics for management reviews, Partner with third-party manufacturers to maintain quality standards, Support continuous improvement of processes and policies
Seniority
Senior, hands-on IC with leadership responsibilities