Quality Engineer Autoinjectors
Ypsomed AG
Full-time
Description du poste
Ypsomed, entreprise leader, recherche un Quality Engineer en assurance qualité. Rejoignez une équipe dynamique et bénéficiez d'un environnement de travail hybride.
Tâches
• Représenter l'assurance qualité dans les projets de développement.
• Assurer la conformité de la documentation selon les normes.
• Collaborer pour résoudre les problèmes de qualité efficacement.
Compétences
• Formation technique en ingénierie ou sciences naturelles requise.
• Compétences analytiques et méthodologiques solides nécessaires.
• Bonne communication en allemand et en anglais requise.
As a leading company in our industry, we have made a name for ourselves through continuous growth. Become part of our successful team and grow with us. We are looking for a motivated person in the Quality Assurance department at our Burgdorf site as
Quality Engineer Autoinjectors | 100%
Ref. No. 7708
Location: Burgdorf | 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, ideally in mechanical engineering, polymer engineering or automation, combined with a degree in the natural sciences (FH, ETH, or university) or equivalent relevant professional experience
• Minimum two years of experience in a comparable role in the MedTech sector or comparable industry
• Strong analytical and methodological skills, with a structured and goal-oriented approach to problem-solving
• Ensuring compliance with applicable standards and regulatory requirements (e.g., ISO 13485:2016)
• Proficiency in ERP systems (e.g., SAP), with familiarity in tools such as TrackWise, JIRA, Power BI, SAP Analytics Cloud or AI-driven applications
• Good communication and language skills in writing and orally (German and English B2 or higher)
Ypsomed - making the treatment of chronic diseases possible
More than 2,000 employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treatment. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life.
Contact
Heiko Sieger
Human Resources Expert Recruiting
+41 (0) 34 424 26 34
Your future place of work
Burgdorf
Tâches
• Représenter l'assurance qualité dans les projets de développement.
• Assurer la conformité de la documentation selon les normes.
• Collaborer pour résoudre les problèmes de qualité efficacement.
Compétences
• Formation technique en ingénierie ou sciences naturelles requise.
• Compétences analytiques et méthodologiques solides nécessaires.
• Bonne communication en allemand et en anglais requise.
As a leading company in our industry, we have made a name for ourselves through continuous growth. Become part of our successful team and grow with us. We are looking for a motivated person in the Quality Assurance department at our Burgdorf site as
Quality Engineer Autoinjectors | 100%
Ref. No. 7708
Location: Burgdorf | 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, ideally in mechanical engineering, polymer engineering or automation, combined with a degree in the natural sciences (FH, ETH, or university) or equivalent relevant professional experience
• Minimum two years of experience in a comparable role in the MedTech sector or comparable industry
• Strong analytical and methodological skills, with a structured and goal-oriented approach to problem-solving
• Ensuring compliance with applicable standards and regulatory requirements (e.g., ISO 13485:2016)
• Proficiency in ERP systems (e.g., SAP), with familiarity in tools such as TrackWise, JIRA, Power BI, SAP Analytics Cloud or AI-driven applications
• Good communication and language skills in writing and orally (German and English B2 or higher)
Ypsomed - making the treatment of chronic diseases possible
More than 2,000 employees worldwide develop and produce injection and infusion systems for self-medication with the Ypsomed Group. We are a successful, rapidly growing, family-owned company headquartered in Burgdorf (CH) with various production sites and subsidiaries around the world. With our market-leading products and solutions, we enable people all over the globe to self-treatment. Despite chronic diseases such as diabetes, obesity, or certain types of cancer, they are provided with the greatest possible quality of life.
Contact
Heiko Sieger
Human Resources Expert Recruiting
+41 (0) 34 424 26 34
Your future place of work
Burgdorf
Informations détaillées
Type de contrat
Full-time
Localisation
Burgdorf
Secteur d'activité
Technologie médicale
Pays
Switzerland
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