Manager, Product Quality Engineering
Core
Managing Product Quality Engineering teams to investigate product complaints, establish post-market surveillance capabilities, and implement corrective actions for medical devices.
Role type
Manager, Product Quality Engineering
Builds
Post-market surveillance programs and corrective action solutions for diabetes care products
Domain
Medical Devices / Diabetes Care / FDA/ISO Regulated Environment
Deliverable
client delivery
Required skills
Root cause analysis, CAPA system management, team leadership, cross-functional collaboration, regulatory compliance knowledge, investigation methodology, project documentation review
Preferred skills
Healthcare industry experience, FDA/ISO regulated environment experience, problem-solving in quality management systems
Technologies
CAPA systems, Quality management systems
Responsibilities
Lead investigations into product complaints and emerging issues, establish processes for new product post-market surveillance, develop and implement investigation methodologies, collaborate with Operations and R&D on cross-functional evaluations, represent the team in divisional escalations, approve quality system documentation
Seniority
Manager, hands-on leadership