Engineer - Degreed II

Minimum 3+ years of work experience in an Operations Quality or Quality Engineering role supporting medical device or pharmaceutical manufacturing. Bachelor's degree (preferably in Engineering, science or a closely related discipline is desired) or equivalent technical experience and demonstrated competence.

Title: Engineer - Degreed II
Location: Austin TX (100% Onsite)
Duration: 9 Months
Shift Time: 8am to 4:00pm
Pay Range: $33/hr to $36/hr (On W2)

We are looking for a“Engineer - Degreed II“to join one of our Fortune 500 clients.

Job Responsibilites:

• Support day-to-day Quality Operations in a medical device manufacturing environment
• Act as Customer Ops QA representative interfacing with Third-Party Manufacturer (TPM)
• Provide oversight of quality records: NCRs, CAPAs, change control, validations, supplier changes, DHRs
• Review and ensure compliant resolution of nonconformances and CAPAs
• Lead/support quality investigations and perform root cause analysis
• Ensure adherence to GMP, FDA, ISO 13485, and QMS requirements
• Review Device History Records (DHRs) and support product release activities
• Partner with manufacturing and engineering to resolve defects and improve processes
• Monitor and report quality KPIs and trends
• Support deviations, validations, and supplier change activities
• Identify and drive continuous improvement initiatives
• Ensure TPM maintains compliance with quality system requirements
• Author/review quality documentation and investigation reports

Education:

• Bachelor's degree (preferably in Engineering, science or a closely related discipline is desired) or equivalent technical experience and demonstrated competence.
• Minimum 3+ years of work experience in an Operations Quality or Quality Engineering role supporting medical device or pharmaceutical manufacturing.
• Hands-on experience working in cleanroom and laboratory environments is preferred.

 

We are looking for the candidate who are eligible to work with any employers without sponsorship.

If you’re interested, please click “Apply” button