Senior Associate Specialist,Quality
Core
Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements and meet specified standards for medical technology products.
Role type
Senior Associate Specialist, Quality
Builds
Total quality management system for the business
Domain
Medical device manufacturing and regulatory compliance
Required skills
Quality management system (QMS) management, regulatory compliance, process effectiveness, ISO 13485, ISO 14971, IEC 62304, FDA 21 CFR 820, software development methodologies, computer system validations
Preferred skills
Medical device QMS requirements, regulatory requirements, functional policy strategy execution
Technologies
ISO 13485, ISO 14971, IEC 62304, FDA 21 CFR 820
Responsibilities
Drive compliance activities around a specific product, site or region; ensure quality and regulatory compliance while driving process effectiveness and efficiency; resolve issues requiring good knowledge and judgment within established procedures; explain technical information to others
Seniority
Senior, hands-on IC