Supplier Quality Engineer II

About This Role

This role involves hands-on project management, collaboration with multi-functional teams, and ensuring that supplier qualification processes align with quality standards and company objectives.

Responsibilities

• Act as the primary technical point of contact with suppliers who provide electronic components and custom assemblies (PCBAs, consoles, cables, batteries, housings, etc.)
• Lead supplier investigations and root cause analysis (5-Why, fishbone) and track/implement corrective and preventive actions
• Monitor supplier performance metrics (PPM, on-time delivery, NCRs) and analyze trends using SPC
• Assess risk through FMEAs and develop process validation plans (MVP, IQ/OQ/PQ) to be executed at supplier
• Act as a technical partner with internal incoming inspection teams to assess defects and manage non-conformance investigations
• Collaborate with engineering, procurement, and manufacturing to resolve quality issues and improve processes
• Compile, analyze, and summarize supplier performance data for Supplier Scorecards

Requirements

• Effective communication skills across all levels of the organization
• Understanding of electrical components and custom assemblies (PCBAs, consoles, cables, batteries, housings, etc.)
• Strong technical writing skills
• Ability to work independently in a fast-paced environment while managing multiple priorities
• Proactive, self-motivated, and able to work independently with minimal supervision

Qualifications

• BS degree in electrical engineering or related engineering field
• 2+ years of related experience

Nice to Have

• Experience in the medical device industry
• MS degree in an electrical engineering field
• Knowledge of cGMP, FDA 820 QSR, ISO 13485, or other Quality Systems
• Knowledge of statistics (hypothesis testing, capability analysis, DOE, MSA), Six Sigma, Lean
• Certifications (CQE, Lead Auditor, Six Sigma, Project Management)

Skills

* Required skills

Benefits