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Sr. Auditor – Quality and Compliance Professional

Job Description

Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated 5 million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.


Internal Audit helps to improve the overall success of Siemens Healthineers operations and processes and provide independent, factual, unbiased assurance to the Managing Board and Audit Committee. As a business partner to Siemens Healthineers executive management, we leverage our expertise in a wide range of topics in order to create impact that drives change with improved financial results.

SHS A is a Global Leadership Development Program where you will work on different assurance engagements for various internal clients globally. The hands-on international exposure, in-depth view into Healthineers operations, and networking opportunities are key elements to taking on a leadership role as your next career step.

This is a role well suited for an ambitious professional looking for the next step as a leader in quality and regulatory management. Alumni of SHS A have gone to various leadership roles within Healthineers, such as global business quality head, global business regulatory head, site quality head, and product quality lead.

This role is in the Americas Region and the incumbent can be based in Tarrytown, NY or Malvern, PA or hybrid (remote and on onsite).


Responsibilities:

  • Represent Internal Audit within Siemens Healthineers, solidifying SHS A as a trusted business partner who helps manage risks for the company.
  • Lead engagements and teams by developing the audit scope, determining the work plan, and establish the risk assessment with the auditee prior to fieldwork to coordinate the execution of the audit scope across multiple sites.
  • Assign sections of the work plan to the team and ensure that potential issues and areas for improvement are identify,  and formulate recommended actions through review of documentation and client inquiry on a wide variety of Healthcare-relevant topics including but not limited to Anti-Corruption: Business Partners, Cybersecurity, Data Privacy, Fraud Prevention, FDA/ISO Regulatory Compliance, Product Lifecycle Management, Business Continuity, Cloud Computing, Factory Operations, and Business Performance. 
  • Leverage the power of digitalization (data mining, data visualization, machine learning, and neural networks) to drive audit productivity, unlock new insights, and pursue “absolute” assurance by analyzing full populations (as opposed to merely sampling).
  • Actively support and monitor the progress of less experienced team members on audit methodology, execution of assigned tasks, and review of their working papers.
  • Provide timely status updates to audit management by communicating observations, engagement risks, and potential roadblocks. 
  • Actively provide and seek clarification amongst team members on engagement task requirements, processes, controls and technical matters as needed. 
  • Prepare working papers and review initial drafts for discussion with audit management.  Discuss cleared audit findings with the auditee and agree on management planned actions. Draft initial sections of the audit report and participate in discussions with management.
  • Be the “Picture of a Leader”; leverage your motivation and expertise to drive change and make impact through collaboration with peers.
  • Contribute to recruiting activities; identify internal and external top talent.
  • Internal audit roles regularly require extensive domestic and international travel (as high as 80%).

Required Knowledge/Skills, Education, and Experience:

  • 5 to 8+ years of experience in quality/process engineering, R&D, and/or quality management role within the medical device or pharmaceutical industry (In-Vitro Diagnostics or Diagnostic Imaging preferred).
  • Strong working knowledge of worldwide cGMPs, regulatory requirements, standards, and quality management systems for medical devices:
    • US FDA (21CFR parts 820 / 801 / 803 / 806 / 1000ff)
    • European MDR and IVDR
    • ISO 13485 / ISO 9001 / ISO 14971 / ISO 19011
  • Bachelor’s degree in engineering, computer science, life-sciences or related fields.
  • Certified ISO 13485 auditor with experience as an auditor in the medical devices, in-vitro diagnostics, or pharmaceutical industry preferred.
  •   ASQ, CQE, or CQA certification preferred.
  • Experience working with regulating authorities (e.g., US Food and Drug Administration).
  • Experience working as an US FDA inspector preferred
  • Industry understanding in the areas of cybersecurity, data privacy, service business models (break/fix, fleet management, enterprise management, etc.), Lean/Six Sigma, and product lifecycle management.
  •  “Digital DNA” with a passion for digitalizing processes and performing predictive analyses.
  •   Excellent people management and leadership skills, conflict resolution, assertiveness, negotiation, and influence management.
  •   Excellent written and verbal communication skills.
  •   Fluent in English (written and spoken). Additional languages a plus.


Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full vaccination for COVID-19 vaccinations for all new hires by their start date, except where prohibited by state law.

(Note: Accommodations may be requested for certain medical or religious reasons)


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.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers.

If you wish to find out more about the specific before applying, please visit: https://usa.healthcare.siemens.com/about.

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

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Organization: Siemens Healthineers

Company: Siemens Medical Solutions (TRE dARE) USA, Inc.

Experience Level: Experienced Professional

Job Type: Full-time



Equal Employment Opportunity Statement
Siemens 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.

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