Quality Assurance Manager Autoinjectors
Quality Assurance Manager Autoinjectors
Quality Assurance Manager Autoinjectors
Quality Assurance Manager Autoinjectors
Ypsomed Holding AG
Pharma, Medizintechnik
Burgdorf
- Art der Anstellung: Vollzeit
- Vor Ort
- Zu den Ersten gehören
Quality Assurance Manager Autoinjectors
Über diesen Job
Ypsomade.
Join our passionate team at Ypsomed and take a key role in shaping the quality culture of our innovative autoinjector platforms. As Quality Assurance Manager, you will be the driving force behind compliant development processes and data-driven decision-making. Together, we ensure patient safety and deliver high-quality solutions to the global MedTech market.
Quality Assurance Manager Autoinjectors | 80 - 100%
| Hybrid
Help us bring to market state-of-the-art medical technology solutions by optimizing processes and ensuring quality through your structured approach.
Your main tasks
- Act as Quality Assurance (design assurance) representative in development projects for platforms and product variants, as well as in Life Cycle Management activities.
- Ensure compliant documentation in the projects and processes acc. to applicable standards, regulations and customer requirements
- Drive the resolution of quality issues through effective collaboration across all organizational levels and functions
- Collaborate in projects and sub-projects for optimisation, harmonization and further development of processes
- Monitor and analyze quality performance indicators and ensure transparent reporting to relevant stakeholders
- Perform investigations, prepare quality reports and apply statistical methods to support data-driven decision-making
- Support quality-related communication with customers and actively participate in internal, customer, and regulatory audits
Your profile
- Technical background (preferentially mechanical engineering / polymer engineering, automation) or equivalent formation in natural sciences (FH, ETH, University) or equivalent relevant professional experience
- Minimum two years of experience in a comparable role in the MedTech sector or comparable industry
- Strong methodical competence and a structured, goal-oriented approach to problem-solving.
- Ability to work within regulated environments, ensuring compliance with applicable standards and regulatory requirements (e.g., ISO 13485:2016)
- Proficient in ERP systems (e.g., SAP) and familiar with additional tools such as TrackWise, JIRA, Power BI, SAP Analytics Cloud, and AI-based applications
- Good communication and language skills in writing and orally (German and English B2 or higher)
Unternehmens-Details
Ypsomed Holding AG
Pharma, Medizintechnik