Manufacturing Quality Improvement Professional

6 days ago


Irving, Texas, United States FRESENIUS USA MANUFACTURING INC Full time
Responsibilities

As a CAPA Engineer at FRESENIUS USA MANUFACTURING INC, your key responsibilities will include:

  • Leading CAPA investigations and implementing corrective actions to ensure product quality and safety
  • Developing and maintaining Master Production Records for medical devices or drugs
  • Collaborating with suppliers to resolve nonconformances and notifications
  • Managing contract manufacturing organization (CMO) complaints and developing Quality Agreements for CMOs, Third-party Vendors, and new parts/services qualifications
  • Participating in corporate, internal, and external audits (FDA and COFEPRIS)
  • Using Trackwise and Windchill platforms and MINITAB to manage quality assurance projects

Requirements:

  • Bachelor's degree in Industrial, Chemical, or Biomedical Engineering or a closely related field
  • 2 years of experience as a Quality Engineer in a manufacturing environment
  • Experience working with ISO 13485, 21 CFR Part 820.100, and participating in corporate, internal, and external audits (FDA and COFEPRIS)
  • Proficiency in Trackwise and Windchill platforms and MINITAB


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