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Sr. Quality & Compliance Professional - Medical Devices

Job Description

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.

 

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a Sr. Quality & Compliance Professional - Auditing, to take 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.

 

Our global team: We are a team of 66,000 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. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers

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 is in the Americas Region and the incumbent can be based in Tarrytown, NY or Malvern, PA with a flexible hybrid arrangement. 

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Sr. Quality & Compliance Professional - Auditing, you will be responsible for:

  • Representing Internal Audit within Siemens Healthineers, solidifying SHS A as a trusted business partner who helps manage risks for the company.
  • Leading 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.
  • Assigning 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. 
  • Leveraging the power of digitalization (data mining, data visualization, machine learning, and neural networks) to drive audit productivity, unlocking new insights, and pursuing “absolute” assurance by analyzing full populations (as opposed to merely sampling).
  • Actively supporting and monitoring the progress of less experienced team members on audit methodology, execution of assigned tasks, and review of their working papers.
  • Providing timely status updates to audit management by communicating observations, engagement risks, and potential roadblocks. 
  • Actively providing and seeking clarification amongst team members on engagement task requirements, processes, controls and technical matters as needed. 
  • Preparing working papers and reviewing initial drafts for discussion with audit management.  Discussing cleared audit findings with the auditee and agreeing on management planned actions. Drafting initial sections of the audit report and participate in discussions with management.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers

  • Being the “Picture of a Leader”; leveraging your motivation and expertise to drive change and make impact through collaboration with peers.
  • Contributing to recruiting activities; identify internal and external top talent.
  • Internal audit roles regularly require extensive domestic and international travel (up to 25%)

Required skills to have for the success of this role

  • 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.

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.  

 

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.

The pay range for this position in NYC or Westchester County, NY   is $98,400 - $135,300 annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience. The annual incentive target is 10% of base pay.  Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay.   Details regarding our benefits can be found herehttps://benefitsatshs.com/index.html

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Organization: Siemens Healthineers

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

Experience Level: Experienced Professional

Full / Part time: Full-time



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