Abbott System Integration Specialist V in Irving, Texas

At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.


-Develops and Executes system related (i.e., hardware, software, labeling and/or assay) verification & validation and/or characterization protocols and supports data package summaries in accordance with governing procedures

  • Identifies and confirms cause of instrument and assay issues, discrepancies, problems or complaints in accordance with governing procedures.

  • Moves the Complaint Handling investigation process forward to closure.

Core Job Responsibilities:

Responsible for implementing and maintaining the effectiveness of the quality system.

  • Creation and approval of assay files for product launches and on-market changes for the ARCHITECT and Alinity systems.

  • Thorough documentation of verification and investigation activities to support Quality system compliance needs.

  • Proficiency in assay file parameters review and the assay file management system.

  • Runs defined protocols / experiments and development of associated data packages and associated

  • documentation.

  • Basic troubleshooting within single functional area and/or protocol.

  • Basic operation of instrument and repairs at customer replaceable level.

  • Responsible for implementing and maintaining the effectiveness of the quality system.

  • Applies quantitative methods, analyzes data, evaluates results, forms conclusions and provides/implements improvements.

  • Develop/modify and Maintain assay file data based on input from assay group

  • Verify content of assay files and ensure Assay File parameters meet system requirements

  • Release Assay Files per approved Design Control and Site procedures

Minimum Qualifications:

Bachelor’s degree in Life Science or closely related discipline is desired; or relevant combination of education or experience.

Minimum Experience/Skills:

· 0-2 years work experience in this job area.

· Knowledge of regulations and standards affecting IVDs and Biologics.

· Good Lab Practice, PC Skills (Word, Excel, Powerpoint), Data representation.

· Can conduct work that conforms to the effectiveness of ADD’s quality system.

· Reviews, generates and documents Verification & Validation or Characterization related inputs.

· Demonstrates use of experimental and data Analysis techniques including statistics, DOE and Six Sigma training.

· Exchanges information with product team members, scientists, engineers, and other systems development personnel.

· Proficient in operation of instruments, and repairs/replacement of CRU parts/sub-assemblies.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email