Quality Engineer - Risk & Complaint Manager, Malvern, Pennsylvania

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

We at Siemens Healthineers are committed to helping healthcare providers globally to succeed in today's dynamic environment. We are inspired to transform the way things are done - because we want what is best for our people, our customers and ultimately the health of mankind.

While we are investing in engineering excellence - leading-edge medical technologies and services, we don't stop there. We're also investing in our 48.000 people with the hearts of pioneers and minds of engineers, highly committed and connected in the healthcare industry.

Join our team now at Siemens Healthineers as Risk and Complaint Manager (m/f) at Digital Health in Malvern (U.S.) or Kitchener (CA).

You want to change your responsibility and to be an active part of our operations? Be an important part of ensuring the safety and effectiveness of Medical Devices and Health Software.

• Plan and execute risk management activities together with the project management and development.
• Work with cross functional teams to identify and evaluate potential safety risks, and then develop risk mitigation measures for hazardous situations which could occur in the use of the Medical Devices and Health Software products.
• Track the implementation of mitigations in close collaboration with product development teams to ensure the effectiveness of the risk control measures.
• Be responsible for all complaint handling activities related to products assigned to you.
• Act at the interface to customer service and product development to drive solutions for complaints.
• Work on safety related complaints and adverse events in close collaboration with technical and clinical experts.
• Lead interdisciplinary teams, like safety CCB and safety council to evaluate the effects of safety complaints and to decide about reporting to authorities.
• Perform reporting of adverse events and field safety corrective actions in the field to the respective authorities.

If you are experienced in the medical industry or in software development, you may be the right person for this position.

• You have successfully mastered an informatics, technical or medical degree or you are a medical-technical expert with professional experience and a sound software background.
• You have multi-year experience in the usage of medical devices in a clinical environment, or risk management, complaint handling, quality management, regulatory affairs management, or project management experience in the development of software.
• You have methodological and practical experience in risk management for medical device and health software.
• You know relevant standards and regulations of risk management, e.g. ISO 14971, IEC 62304, IEC 82304, ISO 13485, ISO 31000.
• You are an experienced auditor and familiar with ISO 9001, ISO 13485, ISO 27001, QSR and standards of MDSAP countries.
• You have experience in participating in international teams. A high degree of skill in English is required. German skills are appreciated.
• You have strong communication skills and are assertive and self-motivated.

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Organization: Siemens Healthineers

Company: Siemens Medical Solutions USA, Inc.

Experience Level: Experienced Professional

Job Type: Full-time

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