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français (Intermédiaire), anglais (Courant), allemand (Élémentaire)
Lieu de travail :
Neuenburg
We are a company that develops and manufactures medical devices for therapeutic applications and markets them worldwide.
We are looking for someone, who will report to the Quality Management Representative as
Tasks
Quality Management
Further development and implementation of quality management system (QMS) within BIOPTRON AG (ISO 13485, MDSAP, CFR 820, SOR/98-282)
Deputy to the Quality Management Representative
Conduct internal audits as per audit program
Provide Quality Management support on the projects
Support and assist the company on 3rd party (external) audits from Notified Bodies and regulatory bodies or Competent Authorities (notified body, ETL-certification, Swissmedic)
Conduct root cause analyses and define and implement CAPAs
Perform the corrective measures resulting from audits
Perform Risk analyses according to ISO 14971
Main responsibility for the installation and updating of compliant technical documentation on all medical and non-medical products manufactured by BIOPTRON AG
Information of management in the case of changes in the standards, which have relevant influence on the company
Conduct the supplier quality management
Maintain the QMS and product compliance to applicable regulations and standards
Maintaining familiarity with company product ranges
Regulatory Affairs
Registration of new products in all requested countries
Maintain all current product registrations worldwide
Maintain Technical Documentation of all Bioptron Products
Deputy to the Responsible for regulatory compliance according art. 15 MDR (PRRC)
Responsibility for all vigilance duties pursuant to current regulations (today they are: EEC/93/42, (EU) 2017/745, ISO 13485, MDSAP, FDA-QSA, Health Canada, etc.)
Guarantee of compliance of all BIOPTRON products in all requested countries
Keeping up to date with changes in regulatory legislation and guidelines
Review and update of all product related printing materials (IFU, labels, packaging, leaflets)
Maintaining familiarity with company product ranges
Qualifications
A minimum of 2 years experience in quality management in the field of industrial production, international regulatory and risk management of medical devices
Good knowledge of ISO 13485,ISO, MDSAP, EN ISO 14971:2020
knowledge of MDR 2017/745, and CRF regulations are an asset.
Hands-on experience and sound understanding of the European processes
Fluent in English
You can expect an extremely interesting working environment with challenging tasks in an international environment in which you can develop your area of responsibility and contribute your ideas. We look forward to receiving your complete application documents in English by e-mail to .