Quality System Manager Audit

vor 6 Stunden

Burgdorf, Schweiz Ypsomed AG Vollzeit

Passion.
Ypsomed is a leading provider of innovative medical technology solutions. With our advanced technologies and services, we improve the quality of life of patients worldwide. To strengthen our team at the Burgdorf site in the QS Audit Services department, we are looking for an experienced person as

Quality System Manager Audit & Shared Service | 80 - 100%Ref. No. 7458 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
  • 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
Your profile
  • 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
  • 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
  • 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
Your Ypsomed work environment

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.

ContactHeiko Sieger
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