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Quality Associate II

Req #: 1800056U_en
Location: Round Lake, IL US
Job Category: Quality
Date Posted: 3/6/2018 5:21:20 PM
Baxter International


About Baxter 


Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.




  • Lead daily departmental activities for areas of direct responsibility.
  • Create and / or analyze operation metrics and reports to identify improvement opportunities
  • Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
  • Participate in external assessments and audits by evaluating and solving product/process problems by providing technical, analytical and supervisory skills Support process with timely closure of observations/audit items. 



Essential Duties and Responsibilities:  

  • Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities. Identify and assess regulatory and quality risk in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.





  • Working knowledge of medical products
  • Excellent computer skills
  • Knowledge of JDE
  • working knowledge ofTrackwise8
  • Good communication, written and oral skills
  • Knowledge of regulations outside United States a plus
  • Self-motivated with the ability to work independently and make decisions
  • Excellent organizational skills, problem solving skills and attention to detail
  • Ability to perform multiple tasks simultaneously and work cross-functionally in a highly-matrixed environment.
  • Ability to drive decisions and actions.
  • Expertise in interpreting regulations and familiarity with GDP and GMP
  • Experience with working in an environment subject to compliance with 21 CFR Parts 7, 11, 803, 806, 810, 820 strong preferred.
 Education and/or Experience:  
  • BS in business or science or equivalent
  • 3-5 years experience in Quality with a medical device / Pharma company or other similarly regulated industry.
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