Supplier Quality Engineer I (Medtech)

TL;DR

Supplier Quality Engineer I (Medtech): Ensuring supply chain quality and compliance for medical device components with an accent on supplier qualifications, corrective actions, and performance monitoring. Focus on resolving supplier-related failures, managing SCARs and SSQs, and ensuring adherence to QMS and ISO 13485 standards.

Location: Alameda, CA. Must be able to work on site

Salary: $76,000 – $100,000 per year

Company

A global healthcare company focused on innovative therapies and medical device manufacturing.

What you will do

• Coordinate day-to-day supplier quality issues with Engineering and Operations.
• Provide technical support for Incoming Quality Control (IQC) and drive process improvements.
• Investigate supplier failures and support corrective and preventive actions.
• Manage Supplier Corrective Action Requests (SCARs) and Second Source Qualifications (SSQs).
• Monitor supplier performance metrics and manage the Approved Supplier List (ASL).
• Ensure compliance with QSR and ISO 13485 regulations.

Requirements

• Bachelor’s degree in engineering, science, or a related field.
• 0–3 years of experience in Quality, Manufacturing, or Engineering.
• Foundational knowledge of quality systems (QSR, ISO 13485).
• Ability to work on site in Alameda, CA.
• Strong analytical skills and proficiency with statistical methods.

Culture & Benefits

• Collaborative teamwork environment with a focus on continuous learning.
• Comprehensive benefits including medical, dental, and vision insurance.
• 401(k) with employer match.
• Paid parental leave, sick time, and a minimum of 15 days accrued vacation.
• 11 paid company holidays per year.