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
Post-market surveillance programs and corrective action solutions for medical devices
Domain
Medical Devices / Diabetes Care / FDA/ISO regulated environment
Required skills
Root cause analysis, CAPA system management, post-market surveillance, team leadership, cross-functional collaboration, regulatory compliance (FDA/ISO), troubleshooting, documentation review
Preferred skills
Healthcare industry experience, Quality Assurance discipline, investigative role experience, problem-solving in CAPA environment
Technologies
CAPA system, ADC Quality System
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 team in escalations; Approve quality system documentation
Seniority
Manager, people leadership