Quality System Manager
In the area of Quality Management, Regulatory & Medical Affairs at the Burgdorf site, we are looking for a technically and sound person as
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.
- Organization and management of audits conducted by external parties (customers, Notified Bodies) and regulatory inspections
- Presenting topics related to design transfer, process validation and production during audits as an expert
- Planning and conducting internal audits as lead or co-auditor
- Support corrective actions to ensure effective implementation
- Collaborate with process owners and related departments to improve QMS processes at global and local level
- Ensure compliance of QMS processes with applicable requirements (e.g. ISO 13485, EU MDR, 21 CFR 820, MDSAP as well as specific requirements in the field). Supporting the timely implementation of new and amended requirements in the QMS processes
- Provide training, support and advice to Ypsomed's business units on requirements and QMS processes in the specialist areas: e.g. design transfer, product realization, change control, audit management, deviation management and document management
- Supporting Ypsomed's international subsidiaries in the application of QMS processes to fulfill requirements
- Support or lead projects related to quality management system improvement, certifications, implementation of processes at new international sites and expansion into new markets (e.g. USA)
- Technical, medical or scientific education
- Further training in the field of quality management of medical devices / GMP
- Experience in quality management in the life science sector (e.g. medical technology, pharmaceutical industry, biotechnology)
- Audit experience
- Experienced with quality management system software (e.g. TrackWise, SAP, etc.)
- Experience in working with authorities, Notified Bodies / site registrations would be an advantage
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.
Christoph Badertscher
HR Recruiting Partner
+41 (0) 34 424 34 58
Burgdorf
Burgdorf
Adresse
Ypsomed AG
2,4 (11 évaluations)
