Coordinator, Quality Systems - Sturgis, MI Plant

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 114,000 colleagues serve people in more than 160 countries.

     

JOB DESCRIPTION:

Job Title: Coordinator, Quality Systems

Working at Abbott 

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to: 

• Production areas that are clean, well-lit and temperature-controlled  
• Training and career development, with onboarding programs for new employees and tuition assistance  
• Financial security through competitive compensation, incentives and retirement plan 
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs, Medical Benefits start day 1 
• Vacation – 120 hours of accrued vacation (1st yr is prorated) + vacation buy program + 3 personal days + 10 paid holidays 
• Retiree Healthcare program 
• Robust 401(k) retirement savings with a generous company match 
• 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 around the world and named one of the most admired companies in the world by Fortune.  
• A stable company with a record of strong financial performance and history of being actively involved in local communities 
• 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.  

The Opportunity  

This position works out of our Sturgis, MI 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. 

For over 70 years, Abbott’s Sturgis, Mich., has been impacting its community while producing products that provide essential nutrition to millions of families around the world. Working here, you’ll feel part of a family that is dedicated to making a difference and helping others. 

What You’ll Work On 

The function of the Quality Systems Coordinator for Sturgis Quality Assurance is to coordinate rework documents with a focus on technical writing, reconciliation, and ABTRAQ record initiation and implementation.  They will also coordinate and ensure correct samples are pulled to meet FDA regulation and company policy for End of Shelf-Life testing as well as other sampling and testing needs. 

• Effectively communicate with Corporate, Division, Operations/QA Management, site QA Project Leader, Quality Engineers, and site Management
• Maintain the rework list via the site tracking document
• Implement CAPA initiations, correction plans, and action plan
• CAPA related projects relevant to rework
• Special project requests from various levels throughout the organization
• Meet with QS employee (backup) to communicate any new changes, etc.
• Ensure holds and isolations have been initiated and address as required and verify all sort/destruct issues are completed and documented in the work order.  This activity is critical in assuring product with quality or safety concerns remains within our control
• Coordinates the QS rework process with manufacturing and support areas
• A strong focus on technical writing is necessary as the employee will be writing manufacturing instructions as well as documenting events in the CAPA system. These documents will be reviewed by regulators and certifying bodies
• Reviews rework packets after completion to audit and reconcile the documents to assure they are correct and complete
• Leads/participates in weekly rework meeting in conj