Quality Systems Engineer - ISO 13485 & Process Improvement

Siemens Healthineers AG; Austin (TX); On-site; USD 96,000 - 133,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k)

Life insurance

Long-term and short-term disability

Paid time off

Paid sick and safe time

Job summary

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Engineer to join our team in Austin, TX. You will act as the site’s primary quality engineering resource, supporting manufacturing operations, supplier quality, and quality systems within an ISO 13485:2016 framework.

You will lead investigations, CAPAs, and continuous improvement efforts, partnering with cross‑functional teams to ensure product quality and regulatory compliance in a scalable, data‑driven environment.

Qualifications

• 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

Responsibilities

• 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.

Skills

Quality Engineering

Manufacturing Operations

ISO 13485

Root Cause Analysis

Data Analysis

Education

Bachelor's degree in Industrial/Mechanical/Manufacturing/Quality Engineering

Tools

SAP

ERP systems

eQMS

Quality reporting tools

Job description

Varian Medical Systems, a Siemens Healthineers company, is seeking a Quality Engineer to join our team in Austin, TX. You will act as the site’s primary quality engineering resource, supporting manufacturing operations, supplier quality, and quality systems within an ISO 13485:2016 framework.

You will lead investigations, CAPAs, and continuous improvement efforts, partnering with cross‑functional teams to ensure product quality and regulatory compliance in a scalable, data‑driven environment.