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Principal Quality Engineer

Company: BAXTER
Location: Saint Paul
Posted on: September 25, 2022

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 Leadership and support to the value stream product teams for biological and/or mechanical medical devices. Ensure proper product design and manufacturing process design and execution for such devices.Essential Duties and Responsibilities

  • Participate on product development teams to improve current product and transfer of the design to manufacturing. Participate in risk management activities (quality planning, product and process risk assessment and risk management), review and approval of process and product validation protocols and reports, review component qualifications, and test method development/validation.
  • Lead site initiatives to implement validation programs, inspection programs, regulatory compliance programs.
  • Set statistically valid inspection requirements, including identifying test methods and sampling plans and assist with designing inspection fixtures. Assure measurement systems are capable using MSA, when applicable.
  • Partner with manufacturing on quality related process improvement projects, lean manufacturing projects, and equipment qualification/validation, through review and approval of protocols and reports.
  • Investigate, analyze, review and report on Product Complaints (Field Events).
  • Participate on and lead process improvement teams to implement quality improvement activities using Lean, and Six-Sigma methods.
  • Be the site lead to implement systems and processes for global alignment Lead or participate in Corrective and Preventive Actions (CAPA).
  • Ensure alignment of site processes to business-wide processes.
  • Manages coaching, training and development of subordinates.Qualifications
    • Job experience or advanced training and demonstrated proficiency in total quality management, statistical methods, quality tools, root cause analysis / resolution, risk analysis, SPC, MSA, and design of experiments.
    • Experience in new product development, materials science, and biocompatibility.
    • Excellent oral and written communication skills.
    • Strong problem solving, technical writing, organizational, leadership, and interpersonal skills.
    • Successful track record of leading large or complex projects and diverse teams.
    • Working knowledge of FDA Quality System Regulations, ISO-13485, and ISO-14971.
    • Proficient MS Office skills including MS-Project and Visio.
    • Must have the ability to read/interpret design prints. Education/ExperienceRequired
      • B.S. degree in Engineering, or related scientific discipline. ASQ CQE certification required if 4 year degree is not in engineering.
      • 6-8 years of experience in quality and/or product development.Preferred:
        • Advanced technical degree preferred.
        • ASQ Certification in Quality Engineering and/or Auditing is highly desirable.
        • Prior supervisory experience.
        • Microbiology and sterilization validation experience highly desirable.
        • Experience with biological products and/ or chemical processing highly desirable.
        • Previous Quality Auditing experience is desirable Equal 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. EEO is the Law EEO is the law - Poster Supplement Pay Transparency Policy Reasonable Accommodations Baxter 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 link here and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice . 048661

Keywords: BAXTER, St. Paul , Principal Quality Engineer, Engineering , Saint Paul, Minnesota

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