Job Description
**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 fa...
**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 fa...