Program Manager, Quality
Core
Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements; ensure projects and products meet specified standards and drive quality culture.
Role type
mid-level quality program manager (medical devices)
Builds
total quality management system for the business
Domain
medical technology / healthcare quality
Required skills
quality management, regulatory compliance, process effectiveness, data analysis, project execution
Preferred skills
medical device industry experience, ISO 13485, FDA CFR 820, EU MDR, country specific regulations
Technologies
ISO 13485, FDA CFR 820, EU MDR
Responsibilities
drive compliance activities around a specific product, site or region; execute and drive quality objectives, metrics, reporting and operating mechanisms; act as a resource for colleagues with less experience; lead small projects with low risks and resource requirements; prioritize information for data analysis
Seniority
Mid-level, some autonomy