Manager, Product Quality Engineering
Core
Lead Product Quality Engineering investigations for product complaints and emerging issues, ensuring new products have post-market surveillance capabilities at launch.
Role type
Manager, Product Quality Engineering
Builds
Corrective actions and quality system documentation for medical devices
Domain
Medical Devices / Diabetes Care / FDA/ISO regulated environment
Deliverable
client delivery
Required skills
Root cause analysis, CAPA management, post-market surveillance, cross-functional collaboration, team leadership, regulatory compliance (FDA/ISO)
Preferred skills
Healthcare industry experience, Quality Assurance discipline, investigative role experience
Technologies
CAPA systems
Responsibilities
Initiate and own investigations for product complaints and trends; Establish processes for new product post-market surveillance; Develop team to isolate root causes and implement solutions; Collaborate with Operations, R&D, and QA on cross-functional evaluations; Represent the group in divisional escalations; Approve project and quality system documentation
