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Business Process Data Analyst
Lake Forest, Illinois  |  Onsite
Contract Position
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Applied on August 1, 2021
Job Id #49120 Posted July 19, 2021


1. Position Summary

  • The UDI Data Analyst will support the review and entry of master product data to populate internal and external global UDID database(s) for initial upload and product information maintenance.
  • Will work with various functional teams (R&D, marketing, regulatory, engineering, manufacturing) on product data gathering and analysis related to global UDI compliance for Abbott medical and in vitro diagnostic devices.
  • Will work with large amounts of data from collection, organizing, to analyzing and be able to report on results.
  • Will develop and maintain a general UDI compliance master dataset based on historical, current, and future UDI implementations. Support project execution activities and drive continuous improvement activities
  • The UDI Data Analyst will interact with various Business Unit stakeholders.
  • The role will be accountable for the delivery of the successful execution of the assigned UDI Tiger Team task ensuring an achievable and successful outcome.
  • This job function has accountability for complying with the applicable elements of the Division Quality System procedures, and the Division project management methodology.

2. Essential Duties and Responsibilities (Key Activities)

  • Carries out duties in compliance with established business policies and procedures.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
  • Responsibility to understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
  • Assist Project Manager as a Tiger Team Member in other daily activities related to the UDI implementation and maintenance activities.
  • Lead the collection and analysis of master product data to identify market specific scope based on project UDI implementation strategy.
  • Utilize various business systems to collect data, address data gaps, and update internal systems as needed to improve data accuracy.
  • Will require collaboration with various functions.
  • Interact with key functional stakeholders to perform engineering assessments on confirmed scope, determine implementation complexity, identify required cost investment (if required), and be able to present a summary to Program Manager for program initialization and planning.
  • Manage project specific data changes throughout the duration of each program and maintain master UDI compliance dataset.
  • Build and maintain a master UDI compliance dataset tool to aid in future data analysis.
  • Manage the tracking of LANSA permissions
  • Support the development of country specific UDI requirements documentation.
  • Support Project Manager during project execution with various data related needs.
  • May be asked to manage project change controls utilizing Abbott’s Agile Quality Management system.
  • Collaborate, communicate, and provide status to key stakeholders. Document No. D10018698 Rev AA Confidential Page 2 of 3 Divisional RA/ QA UDI Data Analyst Job Description Abbott Rapid Diagnostics (ARDx) Division Template No. D10000243 Rev AD
  • Maintain ability to comply with business continuity plan (i.e. Work remotely)
  • Provide input and participate in writing procedures and other documents
  • Other duties as assigned 3. Dimensions – Education / Experience / Skills ESSENTIAL
  • Bachelor’s degree (BS) in a relevant discipline i.e. engineering, data sciences, computer sciences or analytics.
  • Minimum 3-5 years of experience required working in a medical device industry.
  • Experience with the design and implementation of UDI for medical device units
  • Must have experience with and understand the GUDID (Global Unique Device Identifier Database) and the FDA requirements.
  • Must be knowledgeable of UDI regulatory timeline for implementation.
  • Must demonstrate the application of advanced problem-solving methodologies, be detailoriented, a critical-thinker, and experienced at investigating and resolving complex issues
  • Must demonstrate an advanced understanding of the principles of good Technical writing
  • Must be computer literate; proficient in MS Word, PowerPoint, Excel, and Outlook
  • Must have strong written and verbal communication skills

Horizontal is proud to be an Equal Opportunity and Affirmative Action Employer. We seek to provide employment opportunities to talented, qualified candidates regardless of race, color, sex/gender including gender identity and/or expression, national origin, religion, sexual orientation, disability, marital status, citizen status, veteran status, or any other protected classification under federal, state or local law.

In addition, Horizontal will provide reasonable accommodations for qualified individuals with disabilities. If you need to request a reasonable accommodation in order to complete the application or interview process, please contact hr@horizontal.com.

All applicants applying must be legally authorized to work in the country of employment.

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Horizontal is proud to be an Equal Employment Opportunity/Affirmative Action Employer providing a drug-free workplace.

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