Supplier Quality Engineer (Medtech)

TL;DR

Supplier Quality Engineer (Medtech): Managing overall quality performance and compliance of suppliers for life-saving medical devices with an accent on risk reduction and process capability. Focus on executing supplier audits, driving corrective actions, and ensuring compliance with FDA QSR and ISO 13485 standards.

Location: Pawtucket, RI (Onsite)

Salary: $75,000.00 to $105,000.00

Company

A global medical technology company developing innovative lifesaving products such as AEDs, ventilators, and trauma kits to improve patient outcomes.

What you will do

• Lead supplier improvement and development to ensure measurement system and process capability.
• Qualify and manage suppliers to minimize risk and maximize supply chain value.
• Implement supplier management systems compliant with FDA QSR, ISO 13485:2003, and other regulatory standards.
• Conduct supplier audits and manage resulting corrective and preventive actions (CAPA).
• Analyze supplier performance metrics and drive continuous quality improvements.
• Collaborate with Procurement, Engineering, and Production to resolve supplier issues.

Requirements

• Bachelor's Degree in Engineering or a technical field.
• MBA or Master's degree (MS) required.
• 5+ years of relevant experience in supplier quality, engineering, or manufacturing.
• Experience with Quality Management Systems (QMS) and industry standards.
• Ability and willingness to travel up to 30%, including international travel.

Nice to have

• Lead Auditor Certification.
• Six Sigma Greenbelt.

Culture & Benefits

• Mission-driven environment focused on improving patient outcomes and saving lives.
• Career growth opportunities within a fast-growing global organization.
• Comprehensive benefits plans.
• Annual bonus eligibility in accordance with the company's bonus plan.