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Senior Supplier Quality Engineer

Boston $80,000 - $90,000 Permanent

Job Description:

  • Lead and manage supplier quality programs for raw materials, components, and outsourced services
  • Conduct risk assessments and develop strategies for supplier onboarding and lifecycle management
  • Serve as primary point of contact for key suppliers regarding quality issues, audit schedules, and technical reviews
  • Oversee change control processes related to supplier-initiated changes and evaluate impact to product quality
  • Work cross-functionally with QA, Operations, and Regulatory Affairs to meet compliance standards
  • Maintain robust metrics and KPIs to monitor supplier performance and drive improvements
  • Participate in internal and external audits and provide documentation support

Qualifications:

  • Bachelor’s degree in Life Sciences, Engineering, or related discipline
  • 5+ years of supplier quality experience in biotech, pharma, or medical device manufacturing
  • Strong knowledge of cGMP, ISO 13485, and supplier management systems
  • Demonstrated ability to lead audits and implement supplier improvement initiatives
  • Excellent communication, problem-solving, and analytical skills
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