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 Quality Manager (f/md), to support customer-focused process, in alignment with global regions
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.
Your tasks and responsibilities:
- You advise and coach stakeholders from the global process within Customer Services Service Operations, considering all applicable standards and regulations (e.g., ISO 13485, QMSR) to ensure regulatory compliance.
- You support colleagues in defining and adhering to process-specific quality objectives and metrics ensuring that ongoing projects meet the required standards and deliver outcomes in time and quality.
- Your responsibilities include handling CAPAs and verifying their effectiveness.
- You act as an interface to our partner in the country’s organizations and business lines on topics within your area of responsibility.
- You stay informed about the latest trends and developments in quality management.
- You conduct and participate in audits and assessments to verify compliance with relevant standards and regulations.
- You drive innovative digital solutions to improve quality by applying unconventional thinking and by coaching and promoting creative methods.
- You collaborate with all Zones, Countries, and process- and value stream-related stakeholders and teams to ensure regulatory alignment and support.
- You proactively challenge the status quo by identifying pragmatic improvement and innovation opportunities and translating regulatory and quality risks into actionable mitigation measures and decision criteria. You also actively seek opportunities for processing optimization and automation.
To find out more about the specific business, have a look at Customer Services .
Your qualifications and experience:
- You have successfully completed a degree in a scientific or technical field.
- You have many years of professional experience in quality management and project management within the medical device environment.
- You are familiar with the applicable standards and regulations regarding QMS for medical devices, as well as other relevant regulations in an international context.
- You have knowledge of complaint handling process in the environment of a medical device manufacturer is a plus.
- Ideally, you already have some initial experience in information and cybersecurity frameworks and best practices.
- You bring hands-on experience with software quality in medical devices or digital health.
- You are up to date with trends in learning technology (e.g., AI, adaptive learning, AI proctoring, etc.) as well as the related regulatory implications (e.g., AI Act) and understand their impact on business operations.
Your attributes and skills:
- You are able to derive compliant and practical requirements from regulatory demands, best practices, and guidelines that align with lean principles.
- You possess effective communication skills and are fluent in both written and spoken German and English at a professional level.
- You have a quality-relevant understanding of agile methodologies. Even under high workload and changing requirements, you work in a goal-oriented and structured manner.
- You impress with your methodical thinking as well as strong analytical and organizational skills.
- You are open and willing to explore new, innovative, and efficient approaches through our digital infrastructure.
- You possess advanced skills in redesigning, translating, and adapting existing processes to align with and optimize the implementation of new Learning Management System (LMS) infrastructure.
- We win together: You have a strong sense of quality, show initiative to drive topics forward, and enjoy working in interdisciplinary teams to implement standards together.