Quality Manager

vor 1 Woche

Neuenburg, Neuenburg, Schweiz Bioptron Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

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

Quality Manager
(80% - 100%) based in
Neuchâtel, NE

Tasks

Quality Management

· Further development and implementation of quality management system (QMS) within BIOPTRON AG (ISO 13485, MDR, MDSAP)

· Deputy to the Quality Management Representative & PRRC

· Conduct internal audits as per the audit program

· Provide Quality Management support on the projects

· Support and assist the company during external audits and inspections, e.g., Notified Bodies or Competent Authorities

· Lead entire QMS processes, for instance, and not limited to: Management Review, CAPA, RISK, Change Management

· Supervising the quality of records from product realization

· Main responsibility for the installation and updating of compliant technical documentation

· SharePoint / DMS maintenance

· Information on management in the case of changes in the standards, which have a relevant influence on the company

· Conduct the supplier quality management

· Maintain the QMS and product compliance with applicable regulations and standards

· Maintaining familiarity with the company's product ranges

· Entire Market access registration

Qualifications

· A minimum of 2 years of experience in quality management in the field of industrial production, international regulatory, and risk management of medical devices

· Good knowledge of ISO 13485, MDR, MDSAP (ISO 14971, ISO 10993 advantage)

· Fluent in English and French (German advantage)

You can look forward to an engaging and dynamic work environment that offers challenging responsibilities within an international context. This position provides an excellent opportunity to expand your professional scope and actively contribute your ideas. We look forward to receiving your complete application documents in English via email at

.

BIOPTRON AG
, Human Resources, Ms. Silvia Imdorf

Sihleggstrasse 23, 8832 Wollerau, ,

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