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Quality Associate, III

Req #: 180001BF_en
Location: Largo, FL US
Job Category: Quality
Date Posted: 2/20/2018 9:59:20 AM
Baxter International


Successfully perform all the primary activities as defined in the QAI and QA II job positions. Demonstrates standard engineering principles to resolve difficult problems.  Schedules and leads project assignments utilizing engineering techniques with minimal guidance.  Ability to handle multiple projects and demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership.  A functional understanding of FDA, ISO and Baxter Quality systems is also required. 


  • Support daily and ongoing Field Service activities while assisting other areas in the successful performance of these activities.
  • Manage and lead quality system compliance for the Field Service organization
  • Devise new approaches to complex problems through adaptations and modifications of standard technical principles.
  • Manage activities of self in achieving defined quality goals in an efficient, accurate and timely manner.
  • Process engineering evaluations of variance notifications related to field equipment
  • Write, review, analyze and revise written Procedures and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
  • Partners with facilities, divisions, and regions to ensure successful implementation and compliance to procedures / regulations for Field Service.
  • Be involved in and lead multiple process/product improvement projects or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation as it relates to products supported by Field Service.
  • Lead audit ready status efforts for assigned areas and assist other areas in understanding FDA, ISO and Baxter quality requirements. Maintain a high level of expertise in current regulatory requirements.
  • Must be a recognized by all levels of the facility as a subject matter expert in their area and be able to demonstrate leadership ability.
  • Assists and writes validations, audits and assessments, where needed.
  • Understand Quality Engineering strategies and be able to exercise new methods or new avenues of investigation.
  • Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
  • Good interpersonal/communication/influencing/negation skills.
  • Good project management skills
  • Working knowledge of FDA Regulations & ISO 13485, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
  • Must be able to provide solutions that reflect understanding business objectives and cost implications.


  • Bachelor’s degree in Science or Engineering required
  • 5-8 years experience in Quality Engineering or related field.
  • 2-3 years of experience in auditing techniques, interpreting regulations and quality system.
  • Strong technical writing skills. Must be able to clearly document investigations, change control and audit reports
  • Strong technical, analytical and problem solving skills.
  • Good interpersonal, communication, influencing, negotiation skills



Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.

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