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

Responsibilities Include:

• Ensure personal understanding of all quality policy/system items that are personally applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work.
• Manage customer notification translations accordingly.
• Foster cross-functional partnerships and mutual understanding of recalls and field corrective actions.
• Ensuring alignment with QA SSC FCA specialist about actions to be done with the stakeholders responsible for FCA execution.
• Execute consolidation of actions evidence: Customer letters notifications and/or product affected conciliation
• Execution of needed follow-ups to obtain missing information or effectiveness checks in collaboration with cross-functional partners.
• Resolution of issues as required to complete daily work.
• Provide analytical support for key metrics and operational reports.
• Closely monitor the accuracy, the quality and the timelines related to recall data entry and effectiveness checks reporting to senior and corporate management.
• Maintain all FCA documentation in the quality repository.
• Be a change agent for the organization. Identify, facilitate, and implement changes to improve efficiency, compliance and reduce complexity of processes as required.
• Participate and support Quality System Audits in in the regions supported.
• Operate within compliant quality system environments.

Qualifications:

• Requires a bachelor’s degree in life science or related degree.
• Fluent English
• Ability to travel and work virtually with all parts of the region.
• 1 year of experience in a quality role.
• Based in Bogota, Colombia

Preferred Qualifications:

• The ability to speak French
• Previous experience supporting quality system audits.
• Strong technical writing and documentation review skills.
• Strong critical thinking and analytical skills.
• Independent compliance decision maker (based on knowledge of regulations, available relevant information, alternatives, risk).
• Influence management skills: ability to work constructively across all functions of the organization and build relationships
• Experience writing and reviewing of technical documentation.
• Knowledge with SAP, Smartsheet, Map Agile, Power BI are advantageous

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 95,000+ 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