Quality Systems Specialist

Medtronic•Brampton, ON

1d•CA$67,120 - CA$83,900•Hybrid

About The Position

We are seeking a Regional Field Corrective Action (FCA) Coordinator to join Medtronic’s Center-Led Post-Market Vigilance team. In this role, you will be responsible for the effective planning, coordination, and oversight of Field Corrective Actions within Canada in alignment with Medtronic’s established FCA procedures and work instructions. As the primary liaison between regional sales, marketing, and field teams; quality assurance; the Enterprise Core Quality Services (CQS) function; and global Operating Unit (OU) Quality leadership, you will ensure the timely and compliant execution of all FCA activities. This position plays a critical role in protecting patient safety and maintaining regulatory compliance by ensuring that all regional FCAs are carried out efficiently, accurately, and transparently. This role is based in Canada, Brampton with the ability and willingness to work onsite at least three days per week.

Requirements

Bachelor’s degree in Life Sciences or a related field.
Minimum of 2 years of experience in quality systems or regulatory affairs, plus at least 2 years of project management experience in a regulated environment.
Fluency in English, both written and spoken with excellent written and verbal communication skills.
Advanced understanding of Health Canada’s regulatory requirements for medical devices (SOR/98-282), Cells, Tissues, and Organs (SOR/2007-118), and drug products (C.R.C., c. 870).
Basic understanding of global regulatory requirements for medical devices (e.g., FDA, EU MDR, ISO 13485, Health Canada SOR/98-282).
Strong project management capabilities.
Exceptional critical thinking and analytical skills.

Responsibilities

Coordinating FCA Deployment to ensure alignment with regulatory expectations: managing the regional rollout of FCAs, including communication with local/regional Quality and Regulatory Affairs (QARA) departments, field representatives, sales and marketing management.
Documentation & Compliance: ensuring all FCA-related documents, including the Global FCA Plan, Field Safety Notice, and Customer Acknowledgement forms, are documented according to Medtronic’s work instructions, and that regulatory and quality requirements are met.
Regulatory Reporting: ensuring all related regulatory reporting to Health Canada is completed on or before the applicable due date.
Training & Support: providing guidance and training to field staff on FCA procedures and best practices.
Audit Support & Notification: supporting OU and local Audit programs, including providing evidence of FCA Planning activities and appropriate competent authority or notified body notification when needed.
Continuous Improvement: identifying opportunities to enhance FCA processes and collaborating with cross-functional teams to implement improvements.