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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.
Then come and join our global team as Head (f/m/d) of Quality Assurance for Software as a Medical Device (SaMD).
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.
This position is full-time or part-time with a minimum of 28h/week.
Your tasks and responsibilities:
- You will take over the disciplinary management of the team leaders for the areas "Product Quality Management", "Designated Complaint Unit" and "Quality China" at our locations in Forchheim, Erlangen and Shanghai
- Together with the team leaders, you define the strategic orientation of the quality assurance teams and ensure an appropriate level of knowledge and further development of the team members
- You define the global strategy with targets and KPIs for the product quality of the D&A portfolio, including the assessment of product quality in the field, and are responsible for its implementation at all Digital&Automation (D&A) sites (China, Germany, India, USA)
- Together with the Complaint Handling Team Leader, you will define the strategy for post-market surveillance, including post-market clinical follow-up activities as well as product vigilance activities
- Together with your team, you will ensure that D&A development projects comply with regulatory and normative requirements as well as the respective risk management outcomes, and ensure the maintenance and improvement of product and process quality
- You are responsible for defining an efficient process, including its interfaces e.g. to Product Lifecycle Management - and initiate digitalisation projects to automate process steps
- You promote awareness of regulatory and customer-related requirements within the organisation and report quality issues to the D&A management team
- Depending on your qualifications, you will be the deputy of the Quality Management Representative (QMR) / Person Responsible for Regulatory Compliance (PRRC)
To find out more about the specific business, have a look at https://www.siemens-healthineers.com/de/products-services
Your qualifications and experience:
- You have a university degree in the fields of medical technology, law, computer science or comparable
- You have many years of professional experience in quality management and/or regulatory affairs in a medical technology or pharmaceutical environment
- You already have many years of professional experience and further qualifications in this field, but do not have a university degree? Then we also look forward to receiving your application
- You have several years of experience in personnel management and in working in multinational teams
- You have extensive knowledge of medical software applications (SaMD), ideally in the clinical area of radiology
- You have a very sound knowledge of standards (ISO 13485, ISO 14971) and regulatory requirements (e.g. EU MDR/IVDR, Canadian MDR, US FDA 21 CFR), especially in the area of design controls for medical devices - ideally you also had touchpoints with ISO 27001
- Ideally, you have previous experience with modern software development, including platform development and lean and agile practices
Your attributes and skills:
- With your very good written English skills, you can understand technical documentation (product specifications, risk analyses, etc.) and define processes, process adjustments or justifications and assessments
- Your very good oral English skills enable you to act confidently at all organisational levels, both internally and externally, e.g. towards representatives of authorities
- Your excellent communication, networking and moderation skills enable you to deal confidently with internal and external interfaces
- Personally, you are characterised by analytical thinking, a strong focus on results, a high level of assertiveness, initiative and the ability to understand complex technical and process-related interrelationships
- You take the initiative, independently assess opportunities and risks, set ambitious goals and motivate employees to achieve these goals
Our global team:
Siemens Healthineers is a leading global medical technology company. 69,500 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.
As an equal opportunity employer, we welcome applications from individuals with disabilities.
Wish to find out more before applying? Contact us: +49 (9131) / 17 – 1717, if you wish to discuss any initial questions with our recruitment team. The contact person handling this job ad is
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Siemens Healthineers Germany was awarded the Great Place to Work® certificate.
