Varian Medical Systems, Inc.
Internal Audit Program Manager (Hybrid)
Varian Medical Systems, Inc., Seattle, Washington, us, 98127
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.Varian is seeking an Internal Auditor Program Manager. In this role, you will be responsible for managing and executing the Global Audit Program, focusing on internal audits and external regulatory body inspections within Varian. This role will ensure compliance with international standards such as ISO 13485, EU MDR, GMP, and other country-specific regulations. As the Internal Auditor Program Manager, you will work cross-functionally with global teams to maintain certifications and a robust quality system, while fostering continuous improvement through training and best practice sharing.
You are responsible for:Executing and managing the Global Audit program, including medical device regulatory body inspections and internal audit program.Building and maintaining a multi-year audit plan to maintain certifications and ensure coverage of key functions.Training and mentoring internal auditors and sharing best practices from all global internal and external audits to ensure the quality system is robust and effective.Reviewing and approving auditor qualifications.Reviewing and approving internal audit schedules and reports for all sites globally.Utilizing a risk-based approach to ensure best use of resources to administer the audit program.Chairing quarterly audit program update meetings to share performance against metrics, share best practices, and notify site quality leaders about upcoming changes in regulations.Owning Internal Audit procedures and associated electronic tools, updating periodically in response to user and external auditor feedback.
Minimum Qualifications:Bachelor's degree5+ years of experience in medical device quality and/or regulatory affairsExperience hosting and performing audits according to ISO 13485, EU MDR, GMP, and country-specific regulations.Certified lead auditorStrong attention to detail with the ability to focus on a high-level view when necessary.Excellent communication and organizational skillsTeam-oriented with the ability to collaborate with global, cross-functional organizations.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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You are responsible for:Executing and managing the Global Audit program, including medical device regulatory body inspections and internal audit program.Building and maintaining a multi-year audit plan to maintain certifications and ensure coverage of key functions.Training and mentoring internal auditors and sharing best practices from all global internal and external audits to ensure the quality system is robust and effective.Reviewing and approving auditor qualifications.Reviewing and approving internal audit schedules and reports for all sites globally.Utilizing a risk-based approach to ensure best use of resources to administer the audit program.Chairing quarterly audit program update meetings to share performance against metrics, share best practices, and notify site quality leaders about upcoming changes in regulations.Owning Internal Audit procedures and associated electronic tools, updating periodically in response to user and external auditor feedback.
Minimum Qualifications:Bachelor's degree5+ years of experience in medical device quality and/or regulatory affairsExperience hosting and performing audits according to ISO 13485, EU MDR, GMP, and country-specific regulations.Certified lead auditorStrong attention to detail with the ability to focus on a high-level view when necessary.Excellent communication and organizational skillsTeam-oriented with the ability to collaborate with global, cross-functional organizations.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
#J-18808-Ljbffr