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Veterans at Abbott

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Abbott Senior Quality Engineer in Indianapolis, Indiana

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

This position will be based in Westfield, IN. However, there will be an initial training period of up to 12 months in Menlo Park, CA. Applicant must be able to spend up to 12 months in Menlo Park before transferring to Westfield location.

Primary Job Function:

When exception events occur in the manufacturing, lab, validation, microbiology, stability, or complaints area the Quality Engineer will both compile the information and write the exception document for multiple approvals.

Core Job Responsibilities:

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

Major Responsibilities:

  • When exception events occur in the manufacturing, lab, validation, microbiology, stability, or complaints area the Quality Engineer will both compile the information and write the exception document for multiple approvals.

  • Perform investigation activities and then perform thorough documentation of events that occurred.

  • Work with Division Quality Control Investigation reviewers to get feedback and work to resolve questions and concerns identified. Identify and use data sources for investigation and review.

Position Accountability / Scope

This position covers all operational aspects of regulatory compliance from raw material inspection through shipment of final product, impacting the quality of marketed items for domestic and international sales. Failure to maintain compliance with government and internal regulations could cause non-compliant product to reach the market and unfavorable results of government inspections. The incumbent may be required to present supporting data during FDA and internal audits. The incumbent must be able to coordinate activities with other plant employees in order to meet goals and required reporting timelines. The incumbent must present metrics to the various plant functions and be able to resolve data integrity issues in a timely manner.

Minimum Education:

Bachelors Degree in a technical area or Equivalent Experience. Preferred Education: Degree in Technical Area (Engineering, Biology, Chemistry, etc.)

Minimum Experience:

Background: Skills/Experience: Organizational and managerial skills with ability to work well with and direct a team. Ability to compile exception event information by working with a number of people and areas throughout the manufacturing, quality and support areas. Must have technical writing ability to write exception documents, and extensive experience in writing investigations against events that occur. Must be able to write exception

documents that can stand up to FDA scrutiny. Knowledge of data sources to be able to use for investigation review and documentation. Ability to take feedback and training to build better exception documents. Experience (6+ years) in manufacturing tablet plant.

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 corpjat@abbott.com

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