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Essential Functions:A leader of processes to improve supplier performance, drive down cost of poor quality, ability to identify/leverage analytics and data for business problem solving and ability to see issues from multiple viewpoints and understand differing needs of partners. Act as the liaison for suppliers, suggest quality and process improvements while collaborating with internal subject matter experts. Manage Supplier Quality procedures and processes in compliance with ISO, FDA, GMP and other external requirements.Key Responsibilities:Manage Supplier IssuesCollaborate with global and local functions to define actions and priorities for supplier related quality issuesBe a champion of problem solving /root cause analysis activities with suppliers and customers to eliminate recurrence of non-conformancesWork actively with Global Supplier Quality in order to ensure accurate data, act on identified risks, and plan audits for internal and external suppliers and OEMs.Other RequirementsProficient in the development and execution of quality metricsProject planning and proficient in the use of Excel, Word, Access, and quality management softwareEducation Requirements:B.S. Engineering/Operations Management, Biological Sciences or equivalentQuality lead auditor training certificate preferredExperience Requirements:Proven experience in Quality and/or Supplier ManagementSolid experience with ISO 13485 required and 21 CFR Part 820 preferredExcellent oral and written communication skills in English language requiredSolid understanding of six sigma tools such as 8D, FMEA, DMAIC, Value Stream Map and Pareto Analysis preferredKnowledge of statistical tools such as SPC, statistical sampling, DOE preferredWorking Conditions / Travel Requirements:Visits to factories wearing PPE, including cleanroom PPETravel required up to 25% (domestic/international)
