Quality Engineer II (Electronics)

TL;DR

Quality Engineer II (Electronics): Develops and implements quality system elements for new and existing medical device products with an accent on testing, inspection methodology, and regulatory compliance. Focus on performing failure analyses, defect investigations, internal audits, and interfacing with engineering departments, customers, and suppliers.

Location: Alameda, CA

Salary: $95,000 to $127,000

Company

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

What you will do

• Collaborate on development, qualification, testing, and inspection for new and existing products
• Design QC sampling systems, procedures, statistical techniques, and inspection equipment
• Perform failure analyses, defect investigations, and production limitation analyses
• Recommend specification revisions and develop standard operating procedures
• Facilitate internal audits and interface with engineering, customers, and suppliers on quality issues
• Adhere to Quality Management System and ensure team compliance

Requirements

• Associate’s or Bachelor's degree in Engineering, Life Science, or related field with 2+ years of quality engineering experience, preferably in medical devices or regulated industry
• Familiarity with QSR, ISO, and applicable regulations
• Experience with electronic devices and/or PCBAs
• Engineering experience in manufacturing environment recommended, medical device industry preferred
• Excellent verbal, written, and interpersonal communication skills
• Proficiency with MS Word, Excel, and PowerPoint

Culture & Benefits

• Collaborative teamwork environment with constant learning and performance rewards
• Medical, dental, vision, life, AD&D, short and long-term disability insurance
• 401(k) with employer match, paid parental leave, eleven paid holidays
• Minimum fifteen days accrued vacation increasing with tenure, paid sick time