Careers that Change Lives
This role will support Americas SSC organization with day to day support. Will act as first level support for stakeholders involved in FCA activities and act as the Regional Field Corrective action coordinator.
This role will work closely with local quality agents and Commercial local teams for the execution of FCA in country and regulatory reporting closely.
A Day in the Life
Responsibilities may include the following and other duties may be assigned.
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.
Participate in the planning meetings with SBUs of new FCA soon to be launched
Provide to the regions the FCA Package, include FCA Execution plan for the region and provide PDL(product distribution list).
Conduct Kick off FCA meetings with all stakeholders impacted.
Ensuring alignment with QA SSC FCA specialist about actions to be done with the stakeholders responsible for FCA execution.
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.
Support when possible the Notification to the health authority when applicable.
Provide constantly update to the leaders stakeholders or partners of the FCA executions status.
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.
Foster cross-functional partnerships and mutual understanding of recalls and field corrective actions.
Must Have : Minimum Requirements
Requires a bachelor’s degree in life science or related degree
Fluent in Spanish and English.
Ability to travel and work virtually with all parts of the region.
3+ years’ experience in quality role.
Nice to Have
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).
Good understanding of the Medical Device Regulations and the Food and Drugs Acts as pertinent to the position. Working knowledge of ISO 13485, and Medtronic policies and procedures.
Good understanding of Latam regulations for Medical Devices and Drugs regarding Complaint Handling / Mandatory Medical Devices Problem Reporting, Adverse Events reporting and Recalls (basic understanding of International regulations).
Influence management skills; ability to work constructively across all functions of the organization and build relationships
Experience writing and reviewing of technical documentation.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.
We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.
Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.
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. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.
ADA-United States of America) Additional Information
Posting Date : Jun 4, 2021
Travel : No