Now's our time to inspire the future ofhealthcare together.
Siemens Healthineers is a leading global medical technologycompany with over 170 years of experience and 18,000 patents. Morethan 48,000 dedicated colleagues in over 70 countries are driven to shape thefuture of healthcare. We stand with our customers around the world to supportthem in delivering high quality care to their patients. An estimated 5million patients across the globe benefit every day from our innovativetechnologies and services in the areas of diagnostic and therapeuticimaging, laboratory diagnostics and molecular medicine, as well as digitalhealth and enterprise services. This is what truly matters to us.
InternalAudit helps to improve the overall success of Siemens Healthineers operationsand processes and provide independent, factual, unbiased assurance to theManaging Board and Audit Committee. As a business partner to SiemensHealthineers executive management, we leverage our expertise in a wide range oftopics in order to create impact that drives change with improved financialresults.
SHSA is a Global Leadership Development Program where you will work on differentassurance engagements for various internal clients globally. The hands-oninternational exposure, in-depth view into Healthineers operations, andnetworking opportunities are key elements to taking on a leadership role asyour next career step.
Thisis a role well suited for an ambitious professional looking for the next stepas a leader in quality and regulatory management. Alumni of SHS A have gone tovarious leadership roles within Healthineers, such as global business qualityhead, global business regulatory head, site quality head, and product qualitylead.
Thisrole is in the Americas Region and the incumbent can be based in Tarrytown, NY or Malvern, PA or hybrid (remote and on onsite).
Required Knowledge/Skills,Education, and Experience:
- RepresentInternal Audit within Siemens Healthineers, solidifying SHS A as a trustedbusiness partner who helps manage risks for the company.
- Leadengagements and teams by developing the audit scope, determining the work plan,and establish the risk assessment with the auditee prior to fieldwork tocoordinate the execution of the audit scope across multiple sites.
- Assignsections of the work plan to the team and ensure that potential issues and areasfor improvement are identify, andformulate recommended actions through review of documentation and clientinquiry on a wide variety of Healthcare-relevant topics including but notlimited to Anti-Corruption: Business Partners, Cybersecurity, Data Privacy,Fraud Prevention, FDA/ISO Regulatory Compliance, Product Lifecycle Management,Business Continuity, Cloud Computing, Factory Operations, and BusinessPerformance.
- Leveragethe power of digitalization (data mining, data visualization, machine learning,and neural networks) to drive audit productivity, unlock new insights, andpursue "absolute" assurance by analyzing full populations (as opposed to merelysampling).
- Activelysupport and monitor the progress of less experienced team members on auditmethodology, execution of assigned tasks, and review of their working papers.
- Providetimely status updates to audit management by communicating observations,engagement risks, and potential roadblocks.
- Activelyprovide and seek clarification amongst team members on engagement task requirements,processes, controls and technical matters as needed.
- Prepareworking papers and review initial drafts for discussion with audit management. Discuss cleared audit findings with the auditeeand agree on management planned actions. Draft initial sections of the auditreport and participate in discussions with management.
- Be the"Picture of a Leader"; leverage your motivation and expertise to drive changeand make impact through collaboration with peers.
- Contributeto recruiting activities; identify internal and external top talent.
- Internalaudit roles regularly require extensive domestic and international travel (ashigh as 80%).
- 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 inengineering, computer science, life-sciences or related fields.
- Certified ISO 13485auditor with experience as an auditor in the medical devices, in-vitrodiagnostics, or pharmaceutical industry preferred.
- ASQ, CQE, or CQA certification preferred.
- Experience working withregulating authorities (e.g., US Food and Drug Administration).
- Experience working asan US FDA inspector preferred
- Industry understandingin the areas of cybersecurity, data privacy, service business models(break/fix, fleet management, enterprise management, etc.), Lean/Six Sigma, andproduct 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.
SiemensHealthineers has recently announced the next steps in our continued commitmentto prioritize colleague health, comply with customer/business partnerrequirements, and help preserve our business continuity. Going forward, please be aware that SiemensHealthineers requires full vaccination for COVID-19 vaccinations for all newhires 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 valuethose who dedicate their energy and passion to a greater cause. Our people makeus unique as an employer in the med-tech industry. What unites and motivatesour global team is the inspiration of our common purpose: Toinnovate for healthcare, building on our remarkable legacy of pioneering ideasthat translate into even better healthcare products and services. We recognizethat taking ownership of our work allows both us and the company to grow. Weoffer you a flexible and dynamic environment and the space to move beyond yourcomfort zone to grow both personally and professionally.If you want to join us in transforming theway healthcare is delivered, visit our career site at
If you wish to find out more about thespecific before applying, please visit: https://usa.healthcare.siemens.com/about.
As an equal-opportunity employer we are happyto consider applications from individuals with disabilities.
Siemens Medical Solutions (TRE dARE) USA, Inc.Experience Level:
Experienced ProfessionalFull / Part time:
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