APH N, USA
1 day ago
Internal Audit Program Manager (Hybrid)

Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare. For everyone. Everywhere.

At Siemens Healthineers, we offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally.

Our Global Team:

We are a team of more than 68,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

Our Culture:

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.

Varian is looking to hire an Internal Audit Program Manager to lead its Global Audit Program. In this key role, you will oversee and execute internal audits and manage external regulatory inspections, ensuring compliance with international standards such as ISO 13485, EU MDR, GMP, and other country-specific regulations. You will collaborate with global, cross-functional teams to maintain certifications, uphold a strong quality management system, and drive continuous improvement through training initiatives and sharing best practices.

You are responsible for:

Responsible for executing and managing the Global Audit program, including medical device regulatory body inspections and internal audit program.

Building and maintaining multi-year audit plan to maintain certifications and ensure coverage of key functions.

Training and mentoring internal auditors and share 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 risk-based approach to ensure best use of resources to administer the audit program.

Chair 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 procedure and associated electronic tool, updating periodically in response to user and external auditor feedback.


Minimum Qualifications:

Bachelors degree

5+ years experience in medical device quality and/or regulatory affairs

Experience hosting and performing audits according to ISO13485, EU MDR, GMP, and country-specific regulations.

Certified lead auditor

Strong attention to detail with ability to focus on high-level view when necessary.

Excellent communication and organization skills

Team-oriented with ability to collaborate with global, cross-functional organizations.

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose:  To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally. 

Beware of Job Scams:

Please beware of potentially fraudulent job postings or suspicious recruiting activity by persons that are currently posing as Siemens Healthineers recruiters/employees. These scammers may attempt to collect your confidential personal or financial information. If you are concerned that an offer of employment with Siemens Healthineers might be a scam or that the recruiter is not legitimate, please verify by searching for the posting on the Siemens Healthineers Career Site.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities.

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