Quality Systems Engineer - ISO 13485 & CAPA Innovator

onehealthineers; Austin (TX); On-site; AUD 130,000 - 173,000; Full time

Job summary

Varian Medical Systems is seeking a Quality Engineer to join our Austin team. The role serves as a key quality engineering resource across quality systems and operational excellence, driving CAPA, root-cause investigations, and data‑driven improvements in a regulated manufacturing environment.

You will partner with cross‑functional teams to ensure product quality, process effectiveness, and regulatory compliance, supporting new product introductions and manufacturing readiness activities.

Qualifications

• Bachelor's degree in Industrial, Mechanical, Manufacturing, Quality or similar field.
• 2+ years of experience in quality, manufacturing, or process engineering.
• Experience with ISO 13485:2016 or similar QMS requirements.
• Proficient with structured problem‑solving to resolve quality issues.

Responsibilities

• Serve as a key quality engineering resource across quality systems and operational excellence.
• Define and improve quality system processes, procedures, and controlled docs.
• Support manufacturing ops to meet specifications and customer expectations.
• Investigate nonconforming materials and drive CAPA actions.
• Lead root cause investigations and recurrence prevention using structured methods.
• Analyze quality data to identify trends and drive improvements.

Skills

Quality engineering

Root cause analysis

Data analysis

Lean Six Sigma

Education

Bachelor's degree in Industrial, Mechanical, Manufacturing, Quality

Tools

SAP

ERP systems

eQMS

Quality analytics tools

Job description

Varian Medical Systems is seeking a Quality Engineer to join our Austin team. The role serves as a key quality engineering resource across quality systems and operational excellence, driving CAPA, root-cause investigations, and data‑driven improvements in a regulated manufacturing environment.

You will partner with cross‑functional teams to ensure product quality, process effectiveness, and regulatory compliance, supporting new product introductions and manufacturing readiness activities.