Jobbeschreibung

Positionsnummer / Reference Number

PA2205018022021

Position / Job Title

Quality Manager

Aufgaben / Tasks

• Internal professional for documentation of complaints and incidents.
• You create reports on incidents such as, malfunctions or changes in the performance of our products, document them in the vigilance system and track internal processing.
• Ensure that the laws, standards, and regulations in the field of medical devices are adhered to.
• You communicate with the relevant authorities and comply with all national and international reporting regulations.
• Your work is crucial for the risk management, to ensure the release of our products for the market.

Qualifikationen / Qualifications

• University diploma in in engineering or similar qualification
• 3 years experience in the Medical Device Industry, experience in Post-Market Surveillance is an advantage
• Sound knowledge in relevant regulations such as 21 CFR 820, MDR, MDD, and ISO 13485/ IEC 60601
• Able to meet deadlines, respond to the urgent needs of the team, focused on results and multi-tasker
• Team player, but capable of working on their own
• Fluent in German and English

Weitere Informationen / Further Information

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