Supplier Quality Engineer II (Medtech)

TL;DR

Supplier Quality Engineer II (Medtech): Ensuring the supply chain delivers components and materials meeting high quality and compliance standards with an accent on supplier qualifications and performance monitoring. Focus on resolving supplier-related issues, driving corrective actions (SCARs), and ensuring adherence to QMS and regulatory requirements like ISO 13485.

Location: Onsite in Alameda, CA

Salary: $90,000 - $121,000 per year

Company

Global healthcare company focused on developing and manufacturing innovative therapies for challenging medical conditions.

What you will do

• Manage day-to-day supplier quality issues and coordinate resolution with Engineering and Operations.
• Support Incoming Quality Control (IQC) and drive process improvement initiatives.
• Lead Supplier Corrective Actions (SCARs) through root cause analysis and implementation.
• Manage Second Source Qualifications (SSQs) and Supplier Change (SC) activities, including technical risk assessments.
• Monitor and trend supplier performance metrics to identify improvement opportunities.
• Ensure strict adherence to QMS and domestic/international regulations (QSR, ISO 13485).

Requirements

• Bachelor’s degree in engineering, science, or a related field.
• 3+ years of experience in engineering, preferably in a medical device environment.
• Experience in Supplier Quality, Manufacturing, or Quality Engineering roles.
• Working knowledge of quality systems (QSR, ISO 13485) and risk-based quality principles.
• Proficiency with statistical software and standard business tools.
• Ability to travel 10–20%.

Culture & Benefits

• Collaborative teamwork environment with a focus on constant learning and performance rewards.
• Comprehensive benefits package including medical, dental, vision, life, and disability insurance.
• 401(k) plan with employer match.
• Generous paid time off: minimum 15 days of accrued vacation and 11 paid company holidays.
• Paid parental leave and paid sick time.