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Supervisor I, Quality Systems

Company: BAXTER
Location: Moraga
Posted on: August 7, 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. SummaryThis role supports the Quality Systems Manager on meeting key quality deliverables. This position is responsible for direct oversight of functional teams including Document Control, Training, and Batch Release. Additional responsibilities include driving Change Control System and involving the customer complaints management system to ensure products and services are provided per customer requirements. Manage multiple projects and provide support for other Quality Systems such as NCR/CAPA, Complaints, and Quality Audits. Must be able to work with Product / Process development teams, Manufacturing, and support groups at all levels. The position requires interaction with corporate and other Baxter sites and requires a solid understanding of Quality system elements. Preferred to have strong understanding of medical Device regulations as it relates to document control, training, batch release, quality audits, complaints, MDR, Adverse events and change control.Essential Functions

  • Review change control projects and provide the quality approvals for them.
  • Share the change control metrics with the departments
  • Provide metrics for Document Control, Training, and Batch Release teams
  • Organize follow up meetings with change control project owners and department managers
  • Coordinate CCB meeting and generate meeting minute notes.
  • Perform impact assessment when needed
  • Conduct in-depth complaint investigations
  • Approve the complaint evaluation conclusion documents
  • Participate in compliance risk evaluation meetings and distribute the meeting notes
  • Provide oversight and support of batch release process
  • Implements or maintains quality systems procedures and standards
  • Understands and assures conformance to regulations and company procedures
  • Supports internal and external audits
  • Identifies and manages continuous improvement projects with the objective of achieving quality, reliability, and cost improvements.
    • May initiate nonconformance reports, and be involved in the investigation
    • Responsible for coaching, training, and development of junior level employees in change control and as a master trainer
    • May work in special projects/teams May perform other duties as assigned.Qualifications
      • Good understanding of medical device regulations, supervisory and project management skills, knowledge or experience in document control, training, batch release, change control, risk management, NCR/CAPA, and complaint investigations
      • Strong analytical and problem-solving skills
      • Leading/supporting the other departments and /or teams
      • Good communication and leadership skillsEducation
        • BS in relevant Science or engineering and 8 years of experience in GMP
        • Supervisory or group/team leader experience The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law. 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 . 067133

Keywords: BAXTER, San Francisco , Supervisor I, Quality Systems, Other , Moraga, California

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