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Quality Systems Manager

Company: BAXTER
Location: Minnetonka
Posted on: November 14, 2021

Job Description:

This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.-Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.-Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.-SummaryProvide Quality Systems Leadership for the manufacturing and design of biological and mechanical medical devices. Lead quality team responsible for change control, quality planning, training, batch records, incoming inspection, and internal/external auditing.- Lead impactful projects improving the usability and effectiveness of the quality system.-Essential Duties and Responsibilities

  • Lead quality system team, including quality supervisor, technicians and associates.- Drive engagement and support development of team.-
  • Lead cross-functional site initiatives to simplify and streamline the quality system in alignment with Baxter policies and procedures.
  • Oversee internal and external audit processes, including training and readiness activities.-
  • Establish Quality System dashboards to monitor overall health of quality system, including -predictive- metrics to drive improved performance.
  • Drive improvements in functional areas of responsibilities utilizing Lean, and Six-Sigma methods.
  • Support integration of acquired sites into the Baxter Quality System.
  • Lead cross functional change review board and drive improvements in performance metrics.-
  • Manages coaching, training and development of subordinates.Qualifications:Required
    • B.S. degree in Engineering, or related scientific discipline. ASQ CQE certification required if 4-year degree is not in engineering or related scientific discipline.
    • 5+ years' experience in Quality, Manufacturing, Engineering or related field
    • Working knowledge of FDA Quality System Regulations, ISO-13485, and ISO-14971.
    • Excellent oral and written communication skills.
    • Strong problem solving, technical writing, organizational, leadership, and interpersonal skills.
    • Demonstrated Critical Thinking skills with focus on improved performance outcomes and positive business impact.
    • Successful track record of leading large or complex projects and diverse teams.
    • Proficient MS Office skills including MS-Project and Visio.
    • Good communication and leadership skills.
    • Good interpersonal/communication/influencing/negotiation skills.
    • Good project management skills.Preferred:
      • Prior supervisory/leadership experience
      • Quality systems and auditing experience
      • Knowledge of EU Medical Device Regulation (EU MDR 2017/745)
      • Advanced engineering or technical degree
      • ASQ Certification in Quality Engineering and/or Auditing
      • Computer systems validations & process validation experience
      • Experience with mechanical and biological products, and/ or chemical processing#IND-USOPS#LI-TV1Equal Employment OpportunityBaxter 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.- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - --Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the here and let us know the nature of your request along with your contact information. 038030

Keywords: BAXTER, Minnetonka , Quality Systems Manager, Executive , Minnetonka, Minnesota

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