Medtronic
Healthcare
AssocQualitySystemsSpecialist
Neural analysis suggests this role is
optimal for Mid+ candidates.
“Assoc Quality Systems Specialist at Medtronic. Skills: Quality Systems, Regulatory Affairs, Project Management. Coordinate FCA deployment. Manage regional rollout”
What You'll Achieve.
Ensure timely FCA execution; Ensure compliant FCA execution; Protect patient safety; Maintain regulatory compliance; Carry out FCAs efficiently; Carry out FCAs accurately; Carry out FCAs transparently
Industry & Context.
Analytical skills
Onsite 3 days/week
What They're Looking For.
Must Have
Baccalaureate degree
Nice to Have
Bachelor's degree in Life Sciences, 2 years quality systems experience, 2 years regulatory affairs experience, 2 years project management experience, Fluency in English, Basic understanding of global regulatory requirements, Project management capabilities, Exceptional critical thinking skills, Analytical skills
What You'll Do.
Coordinate FCA deployment
Manage regional rollout
Communicate with QARA
Communicate with field representatives
Communicate with sales management
Communicate with marketing management
Ensure FCA document compliance
Document Global FCA Plan
Document Field Safety Notice
Document Customer Acknowledgement forms
Provide guidance on FCA procedures
Provide training on FCA procedures
Support Audit programs
Provide evidence of FCA Planning
Provide competent authority notification
Provide notified body notification
Identify opportunities to enhance FCA processes
Collaborate to implement improvements
How You'll Work.
Team & Collaboration
Cross-functional teams; Regional sales; Marketing; Field quality; Enterprise Core Quality Services; Global Operating Unit Quality leadership
Communication Scope
Written communication; Verbal communication
Process & Methodology
Project management
Full Job Description
At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. # **A Day in the Life** Assoc Quality Systems Spec **Associate Quality Systems Specialist** At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. **A Day in the Life** Medtronic is committed to advancing global healthcare by addressing the needs of more people, in more ways, and in more places around the world. United as one company, we accelerate meaningful innovation — and we can only succeed with the right people on our team. 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. This position would be an 18-month contract with the ability and willingness to work onsite at least three days per week. **Responsibilities may include the following and other duties may be assigned:** * Coordinating FCA Deployment to ensure alignment with regulatory expectations:
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