At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all. Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world.

A Day in the Life

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. Youll 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 Medtronics Center-Led Post-Market Vigilance this role you will be responsible for the effective planning coordination and oversight of Field Corrective Actions within Canada in alignment with Medtronics 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: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 Medtronics 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.

Required Knowledge and Experience:

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 have:

• • Bachelors 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.

Salary Range: $54400- $68000

PLEASE NOTE:

• We use artificial intelligence (AI) to review resumes of candidates and assess their fit based on the criteria outlined in the job posting. We do not use AI to make any final hiring or interview decisions.

• This posting reflects a current genuine vacancy that we are actively recruiting to fill

PHYSICAL JOB REQUIREMENTS

• The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.

Medtronic Canada strives through our vision to build a culture of inclusiveness through our commitment to employment equity and diversity. Discrimination is prohibited on any grounds protected under Canadian Human Rights legislation. Employment applications are encouraged from all members of our community. Upon request candidates with disabilities will be accommodated during the recruitment process.

Benefits & Compensation

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.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position.

Benefits & Compensation

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.

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission to alleviate pain restore health and extend life unites a global team of 95000 passionate people.
We are engineers at heart putting ambitious ideas to work to generate real solutions for real people. From the R&D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves. We have the talent diverse perspectives and guts to engineer the extraordinary.

Learn more about our business mission and our commitment to diversity here