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Quality Engineer II

Artech Information Systems LLC

Job Title: Supplier Quality Engineer II
Job ID: 27298
Duration: 12 Months
Location: North Haven Connecticut 06473
Pay Rate: $45.00 - $50.00/hr on W2

Key Skills:
  • Supplier Quality Engineering in Medical Device industry
  • Supplier Change Requests (SCR), PPAP, Validation, TMV, SCAPA, QMS
  • Quality Plans, Control Plans, PFMEA/FMEA, MSA
  • Supplier qualification, part/process qualification, and change management
  • Contract Manufacturer (CM) management and supplier development
  • CAPA, root cause analysis, corrective/preventive actions
  • ISO 13485, FDA 21 CFR Part 820, GMP compliance
  • Inspection, testing, statistical analysis, and quality documentation
  • Cross-functional collaboration with Engineering, Manufacturing, and Suppliers
Requirements:
  • Bachelor's degree in Engineering, Scientific, Electronics, or related technical field
  • 2+ years relevant experience (4+ years preferred )
  • Medical Device industry experience required
  • Onsite in North Haven, CT (40 hrs/week)
Vacancy posted 5 days ago
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