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Principal Quality Engineer

Req #: 170006B2_en
Location: Round Lake, IL US
Job Category: Quality
Date Posted: 8/11/2017 10:46:27 AM
Baxter International

Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter’s employees are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.

 

The Principal Quality Engineer applies a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise toward the development of new or enhanced products or Quality processes. He/She plans, executes and functionally directs important engineering assignments, which require independent judgment. Design, lead and perform experiments using sound scientific principles. This positions requires a functional understanding of FDA, ISO and Baxter Quality systems.  
   
Essential Duties and Responsibilities:  
  • Applies state of the art techniques in the area of expertise to develop new or improved products and processes
  • Practical understanding of the Design Control process for product development with proficiency in writing and reviewing the design control plans
  • Proficient with Change Control understanding and execution as a Quality assessor and approver
  • May lead a large scale program or several small projects with complex features
  • Independently plans, schedules and leads cross-functional team in detailed phases of the Quality work in a project
  • Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
  • Lead audit ready status efforts for assigned areas and assist other areas within the facility in understanding FDA, ISO and Baxter quality requirements
  • Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
  • Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility
  • Identifies and manages continuous improvement projects with the objective of achieving quality, reliability and cost improvements
  • May supervise one or more engineers or technicians
Qualifications for this role:      
  • Must have experience or advanced training and demonstrate proficiency (e.g. total quality management, statistical methods, understanding of biocompatibility, preclinical and clinical studies during product development, problem analysis and resolution, materials science, test method development and validation, design of experiments and life cycle management of product development)
  • Successful track record of managing wide-ranging activities within the business unit
  • Strong interpersonal/communication/influencing/negotiation skills
  • Good project management skills
  • Recognized as a technical expert by peers and other personnel within the business unit
  • Extensive cross-functional team experience, including technical and non-technical work
  • Ability to organize and present technical and project management overviews without assistance
  • Mechanical aptitude
  • Strong knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices
 Education and Experience      
  • B.S. degree in Engineering
  • 5-8 years’ experience in Quality, Manufacturing, Engineering or related field
  • Demonstrated success in delivering results on several technical/product/Quality challenges
  • Product development experience with implants and/or biologics preferred  

 

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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 email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.

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