Assoc Quality Systems Specialist - 18 months contract
Core
Coordinating and overseeing Field Corrective Actions (FCAs) to ensure regulatory compliance and patient safety for medical devices in Canada.
Role type
Regional Field Corrective Action Coordinator
Builds
Field Safety Notices, Customer Acknowledgement forms, and FCA deployment plans
Domain
Medical device regulatory affairs and quality systems
Deliverable
client delivery
Required skills
Project management, regulatory compliance knowledge, cross-functional coordination, documentation management, training delivery
Preferred skills
Life Sciences degree, 2+ years in quality systems or regulatory affairs, 2+ years in project management, fluency in English
Technologies
None explicitly stated
Responsibilities
Coordinate FCA deployment and communication with regional teams; ensure documentation compliance with global work instructions; provide training to field staff; support audit programs and regulatory notifications; identify process improvement opportunities
Seniority
Associate level, contract role