Quality Operations Engineer II – Medical Devices (Onsite Austin)

ManpowerGroup Global, Inc.; Austin (TX); On-site; USD 45,000 - 50,000; Full time

Job summary

ManpowerGroup Global, Inc. is seeking an Engineer - Degreed II for a Fortune 500 client in Austin, TX on a 9-month, 100% onsite contract.

You will support day-to-day Quality Operations in a medical device manufacturing setting and interface with the TPM for quality oversight. The ideal candidate holds a Bachelor's degree in engineering or a related field and has at least 3 years in quality engineering within medical device/pharma environments, including cleanroom and laboratory experience.

Qualifications

• Bachelor's degree in Engineering or related field; equivalent technical experience acceptable.
• 3+ years in Operations Quality or Quality Engineering in medical device/pharma manufacturing.
• Hands-on experience in cleanroom and laboratory environments.

Responsibilities

• 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.
• 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 in Engineering or closely related discipline

Job description

ManpowerGroup Global, Inc. is seeking an Engineer - Degreed II for a Fortune 500 client in Austin, TX on a 9-month, 100% onsite contract.

You will support day-to-day Quality Operations in a medical device manufacturing setting and interface with the TPM for quality oversight. The ideal candidate holds a Bachelor's degree in engineering or a related field and has at least 3 years in quality engineering within medical device/pharma environments, including cleanroom and laboratory experience.