Quality Assurance Specialist (f/m/d)
12.06.2019 | Employee | 100%

The Quality Assurance professional is responsible for the entire complaint process from raising to closing.

Quality Assurance Specialist (f/m/d)

Our Client is an innovative, global medical device company based in the heart of Switzerland.

Description

  • Functions as primary point of contact for complaints and inquiries received from internal and external sources throughout the whole complaint and inquiry handling process from reception to final response
  • Registering of cases within of complaint and inquiry handling database
  • Maintenance of complaint and inquiry handling database
  • Rigorous documenting of all information within complaint handling files
  • Performs Risk Assessment of Complaints to determine investigation priority, reportability assessment, and Corrective Actions follow-up
  • Assures proper dissemination of information from complaints and inquiries to persons directly responsible for the quality of the product and reporting to (competent) authorities, if applicable
  • Preparation of Complaint Reports and independent treatment of inquiries
  • Presentation and discussion of complaints within the Technical Meeting held every month
  • Performing Quarterly Trend Analysis and Reporting to Management Review
  • Initiation and coordination of Corrective and Preventive Action originating from complaints or other sources
  • Handling of non-conforming products (segregation, reject, rework)
  • Supports corrections, recalls, field safety corrective actions and medical device reporting
  • The candidate is responsible to support reporting of vigilance cases to notified bodies and/or authorities and documenting FSCAs, when needed (functions as FSCA coordinator).
  • Responsible for product risk assessment update
  • Responsible for Post Market Surveillance (PMS) for MGD products
  • Functions as internal auditor
  • Supports the market release process (technical release)
  • Participates in various continuous improvement projects

Profile

  • University Degree in Science or equivalent
  • Background in biology
  • 2 - 5 years of experience in a Quality Function
  • Fluent in English and German / French is a benefit
  • Experience with GMP / ISO 13485 / MDR/IVDR
  • Experience in Microsoft office and SAP

Job Offer

- working for an international market leader

- very good development options (incl. professional training)

- competitive salary package

12.06.2019
Employee, 100%

Contact

Michael Page Switzerland
Quai de la Poste 12 1204 Geneva
1003 Bern
Michael Page
Quai de la Poste 12
Genève

Industry

Human resources / Personnel services
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