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  • Manage CAPA processes in relation to Customer and Internal Audits. Track and trend audit data to drive process and program performance.
  • 5 Reasons to Work at Thermo Fisher Scientific

  • Site Steward for Trackwise
  • Review, edit and approve existing procedures. Create new SOPs as appropriate to close QMS gaps and drive continuous improvement.
  • -Coordinate/schedule customer audits and technical visits.
  • Manage audit observations, CAPA time lines, and commitments
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    Preferred Qualifications:
  • Bachelor's degree.
  • Ability to interact with customers on a frequent basis (Customer facing role)
  • Strong working knowledge of FDA Quality Systems Regulations (21CFR820) and International Quality System Standards (ISO13485).
  • Ability to understand various manufacturing processes and quality processes.
  • Excellent written and communication skills.
  • Ability to interact with/manage all levels of the organization.
  • Ability to develop and implement procedures.
  • Ability to perform investigative processes as well as critical thinking and problem solving.
  • Knowledge of statistical based computer programs such as Excel and/or Minitab, as well as Microsoft Office.
  • Strong Root Cause/Problem Solving skills
  • Minimum Requirements:
  • 5+ years of quality management system experience.
  • Ability to understand various Quality management system processes including ISO 13485 and CFR820.
  • Excellent communication and coaching/teaching skills.
  • Ability to travel both domestic and some foreign.

  • * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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