Quality Engineer

Siemens Healthineers

United States

On-site

USD 80,000 - 110,000

Full time

13 days ago

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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

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 Scottsdale, Arizona. 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 9001:2015-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, incoming inspection, supplier quality management, 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 Scottsdale operation.

In this role, you will mainly be responsible for the following:
  • 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, critical‑to‑quality characteristics, 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.
Minimum Requirements
  • Bachelor's degree in Industrial, Mechanical, Manufacturing, Quality, or a related engineering discipline, with 5+ 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 9001:2015 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
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