Quality Engineer II

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)