Quality and Regulatory Compliance SpecialistASCENT PRO

Description
Requirements
• Minimum five years' experience in an administrative function required
• Minimum one-year experience in a quality/compliance function required
• Basic knowledge of FDA and ISO regulations applicable to medical device industry preferred
• Night Shift with weekends off
Description
The Quality & Regulatory Compliance Specialist Role is part of a wider Global Business Services QA Team which is responsible to maintaining compliance for the AIL Quality Management System. The responsibility of this role it to provide support in maintaining compliance in the Quality and other business Management Systems
Responsibilities and Duties
• Administration and Organization of the QA Mailbox including recognizing where escalation points are required.
• Compliant distribution - Screening incoming requests and progressing where all relevant information is available and verified following local procedures.
• Maintenance of Metrics Updating metrics boards and spreadsheets.
• Liaison with the wider ARDx team Supporting the quality team in execution of cross functional actions.
• Support QA Team structure for AIL Galway activities
• Continuous improvement - Administration and support of the CAPA, NC, Change Order processes
• Cross-functional Team member - represents QA in cross-functional teams where business needs require.
• Support QA structure for GBS AIL activities
Requirements
Minimum education level: Bachelor ́s Degree
Years of experience: 5
Availability for travel: Yes
Availability for change of residence: Yes

Work type
Full Time