Engineer - Degreed II

Location: Austin, TX (100% onsite). Duration: 9 months. Shift: 8 am – 4 pm. Pay: $33 – $36 per hour (W‑2).

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.
• 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.

Requirements

• Minimum 3 + years of experience in an Operations Quality or Quality Engineering role supporting medical device or pharmaceutical manufacturing.
• Hands‑on experience working in cleanroom and laboratory environments (preferred).
• Eligibility to work for any employer without sponsorship.

Education

• Bachelor’s degree (preferably in Engineering, science, or a closely related discipline) or equivalent technical experience and demonstrated competence.

Pay

$33 – $36 per hour (W‑2).

Schedule

8 am – 4 pm, 100% onsite.