Senior Auditor Operational Audit - Quality and Regulatory Compliance (f/m/d)

• Job ID: 514522
• Posted since: 20-Jul-2026
• Organization: Siemens Healthineers
• Field of work: Research & Development
• Company: Siemens Healthineers AG
• Experience level: Experienced Professional
• Job type: Full-time
• Work mode: Hybrid (Remote/Office)
• Employment type: Permanent
• Location(s): Erlangen - - Germany, Forchheim - - Germany, Malvern - Pennsylvania - United States of America, São Paulo - Sao Paulo - Brazil, Tarrytown - New York - United States of America

Do you want to help create the future of healthcare? Our name, Siemens Healthineers, was selected to honor our people who dedicate their energy and passion to this cause. It reflects their pioneering spirit combined with our long history of engineering in the ever-evolving healthcare industry.

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sounds interesting?

Then come and join our global team as Senior Auditor (f/m/d) Operational Audit focusing on Quality and Regulatory Compliance and participate in global audit topics (e.g. within R&D/Engineering) for Siemens Healthineers.

Internal Audit helps to improve the overall success of Siemens Healthineers operations and processes and provides 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 results.

You will work on different assurance engagements for various internal clients globally. By integrating digitalization strategies and engaging with the latest technological developments, you contribute to the development of innovative audit approaches. The hands-on international exposure, in-depth view into Siemens Healthineers operations, and networking opportunities are key elements in taking the next step in your career and assume a significant role in a corporate environment.

Choose the best place for your work – Within the scope of this position, it is possible, in consultation with your manager, to work mobile (within Germany) up to an average volume of 60% of the respective working hours.

Even more flexibility? Mobile working from abroad is possible for up to 30 days a year under certain conditions and in selected countries.

This position can be filled in Germany, Erlangen; USA, Tarrytown/Malvern or Brasil, São Paulo.

Your tasks and responsibilities:

• You act as a trusted business partner to management and contribute to international audit topics across Siemens Healthineers.
• You analyze internal data, risk processes, and external trends to identify and assess significant business risks, providing key input for the audit plan and audit topics.
• You develop risk-based audit programs in line with our audit methodology to address identified Quality and Regulatory Compliance risks.
• You prepare, execute, and lead operational audits (e.g., Quality and Regulatory Compliance), including assuming additional responsibilities such as workstream leadership.
• You collaborate closely with cross-functional stakeholders worldwide to assess business challenges, evaluate controls, and address identified risk areas.
• You identify, develop, and promote digital audit use cases (e.g., data analytics, AI, and process mining) to enhance audit coverage, assurance, and efficiency.
• You document audit observations, risks, and agreed mitigation actions, and produce concise, high-quality audit reports and supporting workpapers.
• You present audit results to management, facilitate discussions on key findings, and align sustainable improvement measures to strengthen business processes.

To find out more about the specific business, have a look at https://www.siemens-healthineers.com/products-services

Your qualifications and experience:

• You have successfully completed a university degree in Engineering, Natural Sciences or a comparable subject.
• You have several years of practical experience within the MedTech industry, with a strong background in Quality Assurance, Regulatory Compliance, or System/Process Engineering (e.g., design controls, purchasing and production process controls, complaint management, CAPA, risk management, Software for medical products, product registration, etc.).
• You have expert knowledge of relevant standards and requirements for medical devices (e.g. B. ISO 13485, ISO 14971, IEC 62304, IEC 60601, QSR, MDR/IVDR, TÜV, FDA)
• You have practical experience in leading and conducting audits of the quality management system for medical devices (e.g. MDSAP); a lead auditor certificate is an advantage
• You bring a strong digital mindset and you are proficient in using modern technologies (e.g., generative AI, advanced analytics, automation) and data-driven methods to support decision-making, and drive organizational performance.

Your attributes and skills:

• You communicate confidently and clearly in English (business fluent); additional language skills, such as German, are an advantage.
• You create compelling and structured presentations for senior stakeholders and communicate insights in a clear, concise, and impactful manner.
• You are skilled in adapting messages for executive audiences and facilitating management discussions with confidence.
• You bring strong analytical and problem-solving skills (e.g. Six sigma methods) and you are able to structure complex information in a logical, transparent way.
• You are committed to continuous learning and actively contribute new ideas and approaches that benefit your team and the wider organization.
• You are willing to travel internationally (up to 30%) to conduct and support audits.

Our global team:

Siemens Healthineers is a leading global medical technology company. 74,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. 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.

Our culture:

Our culture embraces different perspectives, open debate, and the will to challenge convention. Change is a constant aspect of our work. We aspire to lead the change in our industry rather than just react to it. That’s why we invite you to take on new challenges, test your ideas, and celebrate success. Check our Careers Site at https://www.siemens-healthineers.com/de/careers

As an equal opportunity employer, we welcome applications from individuals with disabilities.#myabilityshs

Wish to find out more before applying? Contact us: recruitinggersupport.func@siemens-healthineers.com, if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is Petra Hübener.

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To all recruitment agencies:

Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.

Siemens Healthineers Germany was awarded the Great Place to Work® certificate.