Quality Engineer

Regulatory Jobs; Scottsdale (AZ); On-site; USD 89,000 - 123,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) retirement plan

Life insurance

Long-term and short-term disability

Paid parking/public transportation

Paid time off

Paid sick and safe time

Job summary

Varian Medical Systems is seeking a Quality Engineer to join our Scottsdale, AZ team. This role serves as the site’s primary quality engineering resource, supporting manufacturing operations, incoming inspection, supplier quality, quality systems, and continuous improvement in an ISO 9001:2015 environment.

The Quality Engineer will work with cross-functional teams to develop and sustain scalable quality practices, drive CAPA, and ensure regulatory compliance, product quality, and operational

Qualifications

• Bachelor's degree in Industrial, Mechanical, Manufacturing, Quality or related engineering field and 5+ years in quality/manufacturing/process engineering.
• Experience establishing QMS and quality investigations.
• Working knowledge of ISO 9001:2015 or similar QMS requirements.
• Experience with structured problem-solving and root cause analysis.
• Strong analytical skills to interpret data and drive corrective actions.
• Ability to work full-time onsite in Scottsdale, Arizona.

Responsibilities

• Serve as a key quality engineering resource across manufacturing quality, incoming inspection, supplier quality, quality systems, and operational excellence initiatives.
• Define, implement, and continuously improve quality system processes, procedures, and documentation to support Scottsdale operations and ISO 9001:2015 compliance.
• Support manufacturing operations to ensure products, processes, and quality controls meet specifications, regulatory requirements, and customer expectations.
• Develop and maintain inspection methods, criteria, and controls for product verification.
• Lead supplier quality activities, including investigations and CAPA follow-up.
• Investigate nonconforming materials and drive timely resolution with cross-functional teams.
• Lead root cause investigations, containment actions, and CAPA.
• Analyze data to identify trends and drive improvements.
• Establish KPIs and report on quality performance.

Skills

Quality engineering

Manufacturing

Data analysis

Root cause analysis

Education

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

Tools

SAP

ERP systems

eQMS

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 drive effective corrective actions.
• Ability to work full-time onsite in Scottsdale, Arizona.

Preferred Qualifications

• Experience in an ISO 9001:2015 and/or ISO 13485:2016 regulated manufacturing environment.
• Experience in establishing a Quality Management System (QMS), supporting manufacturing quality, incoming inspection, supplier quality, and 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 Quality Engineer (CQE), Six Sigma Green Belt, or equivalent professional certification preferred.

What will set you apart

• Broad quality engineering experience spanning manufacturing, incoming inspection, supplier quality, and quality systems.
• A practical, hands-on approach to improving processes, solving problems, and supporting manufacturing operations.
• Demonstrated success building scalable quality processes, controls, and systems in a dynamic manufacturing environment.
• Strong collaboration and influencing skills, with a track record of driving sustainable improvements in quality, compliance, and business performance.

#LS-OS1

Who we are

We are a team of more than 72,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How we work

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

To find out more about Siemens Healthineers businesses, please visit our company page here.

Base pay range for this position

$89,220 - $122,672

Factors which may affect starting pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

If this is a commission eligible position the commission eligibility will be in accordance with the terms of the Company's plan. Commissions are based on individual performance and/or company performance.

Benefits

• medical insurance
• dental insurance
• vision insurance
• 401(k) retirement plan.
• life insurance
• long-term and short-term disability insurance
• paid parking/public transportation
• paid time off
• paid sick and safe time.

Equal Employment Opportunity Statement

Siemens Healthineers is an Equal Opportunity and Affimitive Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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A successful candidate must be able to work with controlled technology in accordance with US export control law. It is Siemens Healthineers' policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.

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