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!