Quality Systems Engineer

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

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

Our inspiring and caring environment forms a global community that celebrates diversity and individuality.

We encourage you to step beyond your comfort zone, offering resources and flexibility to foster your professional and personal growth, all while valuing your unique contributions.

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Engineer to join our team in Austin, Texas. As the site's primary quality engineering resource, you will have the opportunity to contribute to important engineering decisions and directly support manufacturing operations, incoming inspection, supplier quality, quality systems, and continuous improvement activities within an ISO 13485:2016 compliant manufacturing environment.

Working closely with Supply Chain, Engineering, Regulatory Affairs, IT, and other cross‑functional teams, the Quality Engineer will help develop, implement, and sustain scalable quality practices that ensure product quality, process effectiveness, regulatory compliance, and operational excellence.

The Quality Engineer will provide hands‑on support for manufacturing quality, nonconformance and CAPA processes, quality systems administration, and operational improvement initiatives. Leveraging quality engineering tools, data‑driven decision‑making, and structured problem‑solving methodologies, this role will identify risks, drive corrective and preventive actions, and establish practical, sustainable quality controls that support the continued growth and success of the Austin, TX operation.

What You will do

• Serve as a key quality engineering resource across quality systems, and operational excellence initiatives.
• Define, implement, maintain, and continuously improve quality system processes, procedures, work instructions, and other related controlled documentation to support Austin operations and ISO 13485:2016 compliance.
• Support manufacturing operations by ensuring products, processes, and quality controls meet established specifications, regulatory requirements, and customer expectations.
• Investigate, document, and support the timely closure of nonconforming materials, components, processes, and finished goods while partnering with Operations, Engineering, Supply Chain, and other stakeholders to drive timely resolution.
• Lead and support root cause investigations, containment actions, corrective and preventive actions (CAPA), and recurrence prevention efforts using structured problem‑solving methodologies.
• Analyze quality system data to identify trends, mitigate risks, and drive data‑based improvements.
• Establish, monitor, and report key quality performance indicators, including yield, defect trends, supplier performance, inspection effectiveness, calibration compliance, and issue closure metrics.
• Support new product introductions, manufacturing readiness activities, process changes, equipment qualification, risk assessments, process validation, and production builds as needed.
• Participate as needed in internal audits, management reviews, document control activities, and other quality system processes to ensure site compliance and audit readiness.
• Partner closely with Operations, Manufacturing Engineering, Supply Chain, Product Quality, Supplier Quality, Quality Systems, and site leadership to resolve quality issues, strengthen process controls, and enhance customer satisfaction.
• Apply Lean, Six Sigma, statistical methods, and continuous improvement tools to reduce variation, improve yield, lower the cost of poor quality, and drive operational excellence.

What You will have

• Bachelor's degree in Industrial, Mechanical, Manufacturing, Quality, or a related engineering discipline, with 2+ years of experience in a quality, manufacturing, or process engineering role.
• Experience supporting manufacturing operations, establishing Quality Management Systems (QMS), quality investigations, and continuous improvement initiatives.
• Working knowledge of ISO 13485:2016 or similar quality management system requirements.
• Experience using structured problem‑solving and root cause analysis methodologies to investigate and resolve quality issues.
• Strong analytical skills with the ability to interpret data, identify trends, and drive effective corrective actions

What will set You apart

• Experience in an ISO 13485:2016 and/or regulated manufacturing environment.
• Experience in establishing a Quality Management System (QMS), supporting investigations, audits, and other elements of quality systems activities.
• Working knowledge of calibration and metrology systems, equipment qualification, process validation, and statistical quality methods.
• Familiarity with continuous improvement and problem‑solving methodologies, including Lean Manufacturing, Six Sigma, SPC, FMEA, and 8D.
• Experience with SAP, ERP systems, electronic quality management systems (eQMS), and quality reporting or analytics tools.
• ASQ Certified Qual