Engineering Investigator, Technical Writer

About the position

This position works out of our Columbus, Ohio plant location in the Abbott Nutrition Division. Our Nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow to keeping adult bodies strong and active. Millions of people around the world count on our leading brands - including Similac, PediaSure, Pedialyte, Ensure, and Glucerna - to help them get the nutrients they need to live their healthiest lives. The Columbus Plant is Abbott's first manufacturing facility in the world, making us a leader in science-backed nutrition products. Working here, you'll be part of a family that works together to produce quality products that make a difference and help keep consumers nourished at every stage of their lives.

Responsibilities

• Evaluates and progress the timely completion of CAPA system activities, including effectiveness checks, raised for nonconformances, potential non-conformances, and/or deviations, as output from the division's Quality System.
• Facilitates the investigation process to ensure that root/potential causes are appropriate and implement effective actions to reduce the occurrence/recurrence of the nonconformance.
• Maintains the effectiveness of the CAPA system records to ensure audit-readiness for internal and external quality system audits within the area.
• Ensures all CAPA-related documentation is managed in a complete, clear, concise, and controlled manner.
• Supports a work environment that ensures team effectiveness by demonstrating full cross functional team support that complies with Corporate and regulatory requirements.
• Supports the attainment of division goals and objectives.
• Accountable to the Quality Organization for achieving mutually agreed upon objectives.
• Supports other organizations in the management of their CAPA actions and provide additional confidence that investigations are initiated and completed in a complete, concise, and timely manner; and that viable corrective actions are identified and implemented to address any non-conformances.
• The CAPA System is a key inspection focus of worldwide regulators and auditors. The system must be usable, simple, sustainable, and well maintained.
• Failure to comply with the primary objectives of this role can result in negative impact to the business such as observations, warning letters, de-certification, or product recalls.
• Decisions and recommendations made by this position impact quality decisions for marketed products and the division's Quality System.

Requirements

• Portfolio of technical writing samples for review required.
• Knowledge of FDA Quality System Regulations (QSR) and/or ISO13485 is preferred.
• Able to apply strategic and quality logic and project management skills to investigation activities ensuring appropriate investigations are conducted.
• Good project management skills to deliver an effective service in a timely manner.
• Attention to detail to ensure accuracy of work that forms part of the Quality System documentation.
• Good written and oral communication skills to ensure effective and succinct report generation, and effective communication with staff at all levels of the organization.
• Able to work independently.
• Ability to understand and accurately translate technical information for a general audience.
• Excellent problem-solving ability and attention to detail.
• Technical knowledge of liquid packaging equipment used in the medical/nutritional industry.
• Experiencing leading detailed investigations to determine root cause of failures in a manufacturing environment.
• Experience using Root Cause Analysis Tools for troubleshooting (5 Whys, Fishbone Diagrams, Fault Tree Analysis, DMAIC process, FMEAs, Process Mapping, etc.)

Nice-to-haves

• Society of Technical Writers certification a plus.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor's degree.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.