Device History Record Reviewer

at  Abbott Laboratories

At Abbott, you will play a crucial role to help people live more fully at all stages of their lives. Abbott is a global healthcare leader, and our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritional products and branded generic medicines. Our 113,000 colleagues have a daily impact on the life of people in more than 160 countries.

QUALIFICATION AND EXPERIENCE

• Minimum Level 6 NFQ qualification or equivalent in a relevant discipline.
• Minimum 2 years experience in manufacturing environment.

• Determines lot suitability for release by reviewing test results against product specifications.
• Assesses the cumulative impact of lot deviations, notes and non-conformances.
• Release product by performing the necessary transactions in Systems Applications and Products (SAP)
• Supports quality operations, and CAPA teams to identify quarantined lots on SAP.
• Audits material and the work of others through the examination, inspection, measurement, or test of raw materials, components, sub-assemblies and documentation.
• Gain knowledge of the manufacturing process by becoming familiar with system applications and critical process steps.
• Utilize the review of manufacturing documentation and protocols to conduct validation.
• Informs personnel of product release issues by providing feedback immediately upon discovering of issues.
• Collaborate with internal customers by meeting regularly, responding to requests and explaining procedures.