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 Write an email.

BIOPTRON AG, Human Resources, Ms. Silvia Imdorf

Sihleggstrasse 23, 8832 Wollerau, 043 888 24 48, www.bioptron.com