Quality Engineer - Manufacturing & CAPA

Siemens Healthineers; United States; On-site; USD 80,000 - 110,000; Full time

Job summary

Varian Medical Systems in Scottsdale, AZ, seeks a Quality Engineer to support manufacturing quality, incoming inspection, supplier quality, quality systems, and continuous improvement within an ISO 9001:2015 environment.

You will lead quality system processes, perform data‑driven analysis, drive CAPAs, and partner with cross‑functional teams to ensure product quality and regulatory compliance while enabling operational excellence at the site.

Qualifications

• Bachelor's degree in Industrial, Mechanical, Manufacturing, Quality, or a related engineering discipline.
• 5+ years' experience in quality, manufacturing, or process engineering.
• Working knowledge of ISO 9001:2015 or similar quality management frameworks.
• Experience using structured problem-solving and root cause analysis methodologies.
• Strong analytical skills with the ability to interpret data and identify trends.

Responsibilities

• Serve as a key quality engineering resource across manufacturing quality, incoming inspection, supplier quality, 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 Scottsdale operations and ISO 9001:2015 compliance.
• Support manufacturing operations by ensuring products, processes, and quality controls meet established specifications, regulatory requirements, and customer expectations.
• Develop and maintain incoming, in-process, and final inspection methods, acceptance criteria, CTQ, and inspection controls to ensure effective product verification.
• Support supplier quality activities, including supplier issue investigations, corrective action follow-up, supplier performance monitoring, and quality documentation reviews.
• Investigate, document, and support the disposition 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 manufacturing, inspection, supplier, calibration, and 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.
• Assist with calibration and metrology program activities, including equipment status management, record maintenance, out‑of‑tolerance investigations, and process improvements.
• Participate as needed in internal audits, management reviews, document control activities, and other quality system processes to ensure site compliance and audit readiness.
• Develop and deliver training on quality procedures, inspection requirements, and quality system processes to support consistent execution across the site.
• 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

Root cause analysis

Lean Six Sigma

Data analysis

Education

Bachelor's degree in Industrial, Mechanical, Manufacturing, Quality, or related engineering

Job description

Varian Medical Systems in Scottsdale, AZ, seeks a Quality Engineer to support manufacturing quality, incoming inspection, supplier quality, quality systems, and continuous improvement within an ISO 9001:2015 environment.

You will lead quality system processes, perform data‑driven analysis, drive CAPAs, and partner with cross‑functional teams to ensure product quality and regulatory compliance while enabling operational excellence at the site.