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Together, we can beat cancer.

At Varian, a Siemens Healthineers Company, we bring together the world's best talent to realize our vision of a world without fear of cancer. Together, we work passionately to develop and deliver easy-to-use, efficient oncology solutions.

We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what's possible, to improve people's lives around the world. We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success.

If you want to be part of this important mission, we want to hear from you.

As CAPA Quality Engineer, you will oversee and facilitate the end-to-end process of product and process Issue Review (IR) and Corrective and Preventive Action (CAPA) investigations, spanning from issue identification to solution implementation and effectiveness monitoring.

The role will play a pivotal role in supporting the execution of IRs/CAPAs within the enterprise-wide Quality Management System (QMS), providing coaching and guidance to IR/CAPA owners to ensure adherence to the quality standards. With a focus on intricate IRs/CAPAs with significant cross-system and enterprise impact, the position involves close collaboration with various Quality Management System stakeholders and Senior Leadership. The primary responsibility will be to support IR/CAPA records within the Supply Chain Organization.

What You will do:

• Facilitate IR/CAPA processes, ensuring adherence to procedures and guiding stakeholders through initiation, documentation, and closure.
• Perform detailed, timely IR/CAPA engineering tasks, assess issue descriptions, and actively participate in root cause analysis and quality problem-solving efforts.
• Mentor and coach Issue Review and CAPA owners on essential elements and best practices, emphasizing containment, root cause analysis, and timely corrective/preventive actions, as well as their associated effectiveness checks.
• Ensure robust, compliant, and prompt execution of CAPA action plans, monitoring progress, and providing support to overcome challenges.
• Analyze quality monitoring data sources and apply statistical techniques to identify existing and potential causes of non-conformances, as well as opportunities for improvement.
• Support management by providing CAPA metrics, aligning processes with organizational goals, and contributing to ongoing improvement initiatives.
• Represent CAPAs during audits, presenting metrics at CAPA Review Board meetings.

What You will have:

• Bachelor's degree in engineering, supply chain management, or another scientific-related field.
• Proven experience of 5+ years in supply chain, quality, and manufacturing operations, with a focus on CAPA processes.
• Strong, practical understanding of aspects related to regulated industries, quality standards, and GMP principles in both manufacturing and the supply chain.
• Proven experience in project and change management, process excellence, and business management techniques.
• Demonstrated problem-solving skills and the ability to understand, analyze, and conduct thorough root cause analyses through the use of specialized tools and techniques across a diverse set of processes, including software and hardware-related design issues.
• Ability to conduct risk assessments as they pertain to CAPAs to prioritize and address critical issues affecting product quality and supply chain efficiency.
• Effective communication and collaboration skills and the ability to collaborate seamlessly with various business areas, cross-functional teams, management, and executives at all levels.
• Ability to lead and facilitate CAPA review meetings, training sessions, and process improvement initiatives.
• Proficiency in using quality management tools and software, as well as supply chain management systems.
• Supply Chain Experience covering portions of manufacturing, supplier management, material inventory control, and/or logistics
• Knowledge of statistical techniques and methodologies for data analysis.

What will set You apart:

• Relevant certifications (e.g., ASQ Certified Quality Engineer, APICS certifications, Lean/Six Sigma Green Belt, etc.) are a plus.
• Practical experience pertaining to the medical device industry, applicable regulations, and standards (e.g., 21 CFR 820, ISO 13485, EU Medical Device Directive (93/42/EEC), EU Medical Device Regulation (2017/745), and Canadian Medical Devices Regulation (SOR/98-282), MDSAP, etc.).
• Proven experience and a track record of establishing specific, measurable, achievable, relevant, and time-bound team goals, objectives, and expectations with clear direction and delegation to meet the project goals and objectives.
• Thorough understanding of software and hardware-related problem-solving and non-conformance management standards and methodologies.
• Practical knowledge and the ability to identify and categorize potential risks based on industry standards (e.g., ISO 31000:2018, ISO 14971:2019, etc.).
• Experience in collaborating with cross-functional teams, developing, organizing, and prioritizing key executive leadership and committee activities to facilitate strategic decision-making activities.
• Technical proficiency with Enterprise Resource Planning (ERP) systems, preferably SAP HANA, SAP Manufacturing Execution System (MES), and Excellence through Quality (EtQ), or equivalent.
• Experience in overseeing the measurement and reporting of performance, ensuring that data is accurately collected, analyzed, and communicated to stakeholders at all levels.

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Fighting cancer calls for big ideas.

We envision a world without fear of cancer. Achieving this vision takes dedication and commitment from all of us, every single day. That's why we celebrate and value the distinctly beautiful and intersectional identities of each of our employees. We are a mirror of our patient-base, which allows us to innovate. Big ideas come from everywhere, and the best ideas are fostered by our unique individual experiences. At Varian, we encourage you to bring your whole self to work and believe your bold and authentic perspective will help to power more victories over cancer.

TogetherWeFight

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Equal Employment Opportunity Statement

Varian is an Equal Opportunity and Affirmative 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.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Varian follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more,Click here.

The base pay range for this position is

The pay wage range shown is based on the job posting's primary location. Actual compensation packages are based on a wide array of factors, including but not limited to skill set, experience, certifications, and location.