Assoc Quality Systems Specialist - 18 months contract
About The Position
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. 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 position would be an 18-month contract with the ability and willingness to work onsite at least three days per week.
Requirements
- Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A), 0 years of experience required.
Nice To Haves
- 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
- 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.
- 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.
Benefits
- competitive Salary and flexible Benefits Package
- A wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
