Quality Engineer III

Job Title: Quality Engineer III
Location: Pleasanton, CA
Pay Range: $35 to $45/hr on W2 
Mode: 12 Months / 100% Onsite 

What's the Job?

• Provide quality system support including CAPA management, audit readiness, and quality metrics support.
• Ensure compliance with FDA regulations, ISO 13485, and other regulatory standards for heart failure medical devices.
• Lead risk analysis activities, including FMEA updates, to support product safety and performance.
• Support process validation, product validation, and test method validation activities to optimize manufacturing processes.
• Collaborate with cross-functional teams to monitor manufacturing quality, investigate nonconformances, and implement corrective actions.

What's Needed?

• Bachelor’s degree in Engineering or a related technical field.
• 3-5 years of experience in medical device quality engineering, preferably within cardiovascular or heart failure technologies.
• Proficiency in statistical tools and a strong understanding of ISO 13485, FDA 21 CFR 820, and validation principles.
• Experience supporting implantable or Class III cardiovascular devices is preferred.
• Excellent communication skills and the ability to work collaboratively across teams.

Upon completion of waiting period consultants are eligible for:

• Medical and Prescription Drug Plans
• Dental Plan
• Vision Plan
• Health Savings Account
• Health Flexible Spending Account
• Dependent Care Flexible Spending Account
• Supplemental Life Insurance
• Short Term and Long Term Disability Insurance
• Business Travel Insurance
• 401(k), Plus Match
• Weekly Pay

If this is a role that interests you and you'd like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!