Supplier Quality Engineer

Responsibilities

• Manage supplier quality engineering deliverables specifically for the plastics category to support sourcing strategies and production continuity
• Develop and monitor key performance indicators (KPIs) and dashboards to track supplier health and capability
• Lead root cause analysis for supplier-related non-conforming products and drive corrective actions via Supplier Corrective Action Reports (SCAR)
• Oversee supplier selection, production part approval processes (PPAP), and process capability analysis
• Coordinate technical assessments and documentation for supplier change requests
• Partner with cross-functional teams including Manufacturing, Design Engineering, and Procurement to mitigate product and compliance risks
• Conduct supplier quality system, process, and for-cause audits

Requirements

• Bachelor's degree in Mechanical Engineering, Industrial Engineering, or a related field
• 0-3 years of progressive experience in medical device supplier quality, manufacturing, or engineering
• Strong knowledge of plastic injection molding, including tool design, material selection, and design for manufacturability (DFM)
• Understanding of regulatory frameworks including 21 CFR Part 820 and Part 11
• Proficiency with PPAP, DOE, SPC, GR&R, and control plans
• Excellent analytical, problem-solving, and communication skills

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• Employee wellness programs
• Competitive annual base salary range

About the Company

Insulet Corporation is an innovative medical device company dedicated to simplifying life for people with diabetes through its Omnipod product platform. The company provides unique, wearable, and tubeless insulin delivery solutions that integrate with continuous glucose monitors to improve health outcomes.