Quality Professional – Legal Manufacturer Support
Abbott
- Galway
- Permanent
- Full-time
- Provide support to the implementation of the applicable quality system at ARDx ID Galway.
- Provide compliance oversight and guidance for design transfer activities for both entity & IVDR transfers and NPI, as assigned.
- Maintain awareness of applicable quality standards that regulate our industry. Maintain vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
- Support and/or lead the review and approval of quality system procedures and design records.
- Support and/or lead the development and update of associated Risk Management files.
- Ensure compliant documentation, carrying out tasks related to area of responsibility with management oversight.
- Support and/or lead product and process improvement activities from a quality perspective, ensuring supporting information/rationale for change including reasons and justifications is acceptable.
- Contribute to defining and timely achievement of overall design transfer project goals related to design control from transfer through product launch as assigned.
- Support and lead the development and implementation compliant solutions to problems/issues arising during design transfer/control activities, ensuring appropriate documentation of the event and subsequent resolution from a CAPA perspective.
- Receives general direction and exercises considerable discretion to work own detail. Recommends possible solutions.
- Ensures compliant documentation; carrying out tasks relating to area of responsibility with management oversight.
- At least 3 year’s work experience in a related field experience; less experience may be appropriate with advance degree.
- Preferred experience in the Healthcare industry.
- Has a history of completing successful projects and driving positive compliance outcomes.
Galway : Parkmore East Business ParkADDITIONAL LOCATIONS:WORK SHIFT: Ie - 37.5Hst0 (Ireland)TRAVEL: Not specifiedMEDICAL SURVEILLANCE: Not ApplicableSIGNIFICANT WORK ACTIVITIES: Not Applicable