Project Coordinator III
A Day in the Life
This role will support FCA Global Region Center Led organization with day-to-day support. Will act as a support for stakeholders involved in FCA activities. This role will work closely with the stakeholders for the correct development of the process in country and regulatory reporting closely
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.
- Provide to the regions the guidance according to the correct handling of the process.
- Ensuring alignment with QA SSC FCA specialist about actions to be done with the stakeholders responsible for FCA execution.
- Manage follow-ups to obtain missing information to close the request from OU, according to consignee list.
· Manage SAP data to confirm information and support conciliation process.
· Execute consolidation of actions evidence: Customer letters notifications and/or product affected conciliation
· 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.
· Train FCA process if need it.
· Be a change agent for the organization. Identify, facilitate, and implement changes to improve efficiency, compliance and reduce complexity of processes as required.
· 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 English. · 3-6 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 international regulations for Medical Devices and Drugs regarding PMV/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.
About Medtronic
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)
