Role Responsibilities:
Participation in Complaint Triage meetings for review of the complaint events to determine FAR requirements.
Coordination/Generation of Initial/Follow-up/Final FARs, assuring that timing requirements are met for issuance of Initial and Follow-up FARs.
Communication with key site personnel for any information required to generate the FARs and address review feedback.
Communication with Senior Management reviewers/approvers regarding review feedback and alignment on updates required in the FARs.
Provide audit support with timely data preparation to address inspection requests related to Complaints, FARs and Market Actions.
Strong technical writing skills.
Solid analytical skills and attention to detail are important for this job function to ensure accuracy of the FARs and alignment of the FAR content with the investigation completed for the event.
Qualifications:
Bachelor's Degree Required
Proficiency with MS Office applications (Word, Excel, PowerPoint, Visio, etc.)
Ability to be flexible, resilient, and adaptable to changing priorities in a fast paced, high pressure environment
Strong analytical and problem solving skills
Self-Motivated with a proven record of taking the initiative
Able to work with minimal supervision
Has strong interpersonal skills and ability to communicate with diverse groups and individuals
Strong technical writing skills
Good organizational skills