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Quality Assurance Specialist

4 weeks ago

Madison, Wisconsin, United States Thermo Fisher Scientific Full time

Key Responsibilities:

  • Collaborate with global and local functions to define actions and priorities for supplier-related quality issues.
  • Lead problem-solving and root cause analysis activities with suppliers and customers to eliminate recurrence of non-conformances.
  • Participate in strategic supplier development based on risks identified through the Supply Risk Mitigation team.

Requirements:

  • Proficient in quality metrics development and execution.
  • Project planning and proficient in the use of Excel, Word, Access, and quality management software.
  • Engineering/Operations Management, Biological Sciences, or equivalent degree.
  • Quality lead auditor training certificate preferred.
  • Minimum 5 years of experience in supplier management.
  • Solid experience with ISO 13485 required and 21 CFR Part 820 preferred.
  • Excellent oral and written communication skills in English language required.
  • Solid understanding of six sigma tools such as 8D, FMEA, DMAIC, Value Stream Map, and Pareto Analysis preferred.
  • Knowledge of statistical tools such as SPC, statistical sampling, DOE preferred.
  • Power BI and Data Analytic skills required.

Working Conditions / Travel Requirements:

  • Visits to factories wearing PPE, including cleanroom PPE.
  • Travel required (domestic/international).