Quality System Manager Audit

Vor 4 Tagen


Verwaltungskreis Emmental BE, Schweiz Ypsomed AG Vollzeit
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.

  • Ensure compliance of QMS processes with applicable requirements (e.g. ISO 13485, EU MDR, 21 CFR 820, MDSAP and specific requirements in the respective area)
  • Organization and management of audits carried out by external parties (customer, authority, certification body)
  • Planning and conducting internal audits as lead or co-auditor including documentation of all audits and corresponding audit program and reporting (KPI)
  • Collaborating with process owners and related departments to improve QMS processes at global and local level including investigations referenced to audit findings and the definition and implementation of corrective actions to ensure effective implementation
  • Training, support and advice for the Ypsomed business units on requirements and QMS processes in the specialist areas: e.g. IT, sustainability, change control, audit management, deviation management and documents
  • Support or management of projects in connection with the improvement of the quality management system, certifications, implementation of processes at new international locations and expansion into new markets
  • Presentation of topics related to IT & CSV in audits

  • Completed technical, medical or scientific training
  • Advanced 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 (internal and external)
  • Knowledge of quality management system software (e.g. TrackWise, SAP)
  • Experience in working with authorities, notified bodies and site registrations is an advantage
  • Good written and spoken English skills

Your benefits

Pension fund
Ypsomed covers 55% of the pension contributions

Mobility support
Charging stations, Swiss Half Fare Card, parking, close to public transport

Free sport facilities
Affordable or free gyms all over Switzerland

Family friendly
Financial contributions to childcare

Working hours
Shiftwork, annual working hours, part-time

FlexWork
Work where and when you want (in Switzerland)

Up-to-date work environment
Up-to-date production, offices, break areas

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