V

Varian

Tech-enabled radiation oncology hardware and software

Quality Engineer

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeCary, NC, USA$89.2k - $122.7kHybrid

About the Job

Requirements

  • A bachelor's or master's degree in Quality, Engineering, Natural Science, or a related discipline is preferred, along with experience in the medical device industry.
  • At least 3 years of experience in Quality Management Systems within a regulated medical device environment at a global company; 5 to 7 years is preferred.
  • Auditor certification is required; Lead Auditor certification is preferred.
  • Expert knowledge of applicable medical-device standards, such as ISO 13485 and FDA 21 CFR QMSR.
  • Ability to collaborate across teams and regions with intercultural sensitivity.
  • Ability to make decisions and build consensus across multiple organizational levels.
  • Ability to develop presentations tailored to different audiences and stakeholder needs.
  • Willingness to travel as needed.

Responsibilities

  • Participate in audits and partner with cross-functional teams to strengthen quality processes and promote continuous improvement.
  • Lead internal and supplier audits and partner with stakeholders to support internal and external audit activities.
  • Own and oversee the end-to-end Corrective and Preventive Action (CAPA) process as the CAPA Management Process Manager.
  • Lead cross-functional CAPA meetings, coach and support CAPA Owners and Quality Managers, moderate CAPA Steering Board meetings, and serve as the Customer Services CAPA process subject matter expert during audits.
  • Manage assigned process changes to meet timelines while considering user needs, operational impact, and implementation effort when developing or contributing to process updates.
  • Design and continuously improve process-related training materials for assigned processes.

Desired Qualifications

  • A bachelor's or master's degree in Quality, Engineering, Natural Science, or a related discipline, with experience in the medical device industry.
  • 5 to 7 years of experience in Quality Management Systems within a regulated medical device environment at a global company.
  • Lead Auditor certification.

About the Company

Varian

Tech-enabled radiation oncology hardware and software

Varian, part of Siemens Healthineers, focuses on oncology by providing integrated radiation oncology solutions that combine software, hardware, patient data, and care teams. Its offerings include treatment-planning software, radiation therapy machines, and data-management systems that work together to enable precise cancer treatments. The company differentiates itself through an integrated platform approach and services like Oncology-as-a-Service (OaaS), which lets healthcare providers adopt advanced radiation oncology with ongoing service support rather than large upfront investments. Varian serves healthcare providers such as hospitals and cancer centers, helping them deliver coordinated care and improve patient outcomes. Its goal is to reduce the fear of cancer by using data and technology to support clinicians in delivering effective treatments.

Company size
5,001-10,000
Company stage
IPO
Headquarters
Palo Alto, CA
Founded
1948

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