Quality Assurance Manager Autoinjectors | 100%
- Employment type
- Full-time
- Location
- Burgdorf · Remote possible
- First posted
At Ypsomed, we shape the future of medical technology together - with the goal of sustainably improving the quality of life for people with chronic diseases. We promote an open and inclusive corporate culture in which diversity is valued and new perspectives are welcome. Our employees take responsibility, work interdisciplinary, and develop innovative solutions with real social added value.
Actively help shape the quality of our innovative MedTech products and contribute your expertise to exciting development and life-cycle management projects. As Quality Assurance Manager Autoinjectors, you combine technical know-how with analytical thinking and work together with various specialist departments on sustainable solutions and the continuous further development of our products and processes.
Quality Assurance Manager Autoinjectors | 100% #
Ref-Nr. 8152
Work location:
Burgdorf
| Hybrid
Your main tasks ###
- Taking on the role as Quality Assurance representative (Design Assurance) in development projects for platform products and their product variants, as well as within the framework of life-cycle management activities
- Ensuring compliant and traceable documentation in projects and processes according to applicable standards, regulatory requirements, and customer specifications
- Analysis of quality problems as well as initiation and advancement of sustainable solutions in cooperation with the relevant specialist departments
- Participation in projects and sub-projects for the optimization, harmonization, and further development of processes
- Monitoring and analysis of quality metrics as well as ensuring transparent reporting to the relevant stakeholders
- Carrying out investigations, creating quality reports, and applying statistical methods to support data-based decisions
- Coordination and active participation in quality-related communication with customers
Your profile ###
- Technical background, preferably in mechanical engineering, plastics technology, or automation, or a comparable education in the field of natural sciences (FH, ETH, university) or equivalent relevant professional experience
- At least 2 years of professional experience in a comparable function in the MedTech industry or a comparable industry
- Experience in dealing with regulated environments and in ensuring compliance with relevant standards and regulatory requirements, for example ISO 13485:2016
- Strong methodical competence as well as a structured and goal-oriented approach to problem-solving
- Good user knowledge of ERP systems (e.g., SAP) as well as experience with other tools such as TrackWise, JIRA, Power BI, SAP Analytics Cloud, and AI-based applications
- Good oral and written communication skills in German and English (at least B2)
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Posted 4 days ago