Medtronic is a leader in global healthcare technology, dedicated to addressing the most challenging health problems. They are seeking an Associate Quality Systems Specialist to coordinate Field Corrective Actions (FCA) within Canada, ensuring compliance with regulatory standards and effective communication among various teams.
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
Skills
- 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
- + 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
Benefits
- Medtronic offers a competitive Salary and flexible Benefits Package
- A commitment to our employees lives at the core of our values
- We recognize their contributions
- They share in the success they help to create
- We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage
Company Overview
Medtronic is a healthcare technology company that designs and develops AI-based products and solutions for the medical industry. It was founded in 1949, and is headquartered in Minneapolis, Minnesota, USA, with a workforce of 10001+ employees. Its website is https://www.medtronic.com.