Business Unit: Operational Review
Requisition Number: 237700
Primary Location: United States-Pennsylvania-Malvern
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 80%
Auditor 4 - Internal Audit
If you really want to make a difference - make it with 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 role resides within the America’s Region.
Your new role – challenging and future-oriented
· Represent Internal Audit within Siemens Healthineers, solidifying SHS A as a trusted business partner who helps manage risks for the company
· Assist in leading engagements and teams by reviewing the audit scope, determining the work plan, and participating in the risk assessment with the auditee prior to fieldwork to coordinate the execution of the audit scope across multiple sites.
· Execute assigned sections of the work plan to identify potential issues, areas for improvement, 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 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.
· 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 national and international travel (as high as 80%)
Your qualifications – solid and appropriate
· 5 to 8 years of experience in project management, operations, engineering, quality management, or accounting/controlling role within the medical device industry (IVD or Diagnostic Imaging preferred)
· Strong working knowledge of worldwide cGMPs, regulatory requirements, standards, and quality management systems for medical devices:
o US FDA (21CFR parts 820 / 801 / 803 / 806 / 1000ff)
o European MDD and IVDD
o ISO 13485 / ISO 9001
· Certified ISO 13485 auditor with experience as an auditor in the medical devices, in-vitro diagnostics, or pharmaceutical industry prederred
· ASQ, CQE, or CQA certification preferred