Your tasks

• You ensure compliance with and continuous improvement of the quality management system according to EN ISO 13485 and the applicable regulatory requirements.
• You maintain, update and monitor technical product documentation and QMS documents both digitally and in paper form.
• You prepare internal and external audits, accompany their execution, and support the implementation of the results.
• You are responsible for releasing finished products to the market, taking into account all quality-relevant requirements.
• You coordinate and monitor corrective and preventive actions (CAPA) until their successful implementation.
• You plan and oversee certification processes with notified bodies and ensure the maintenance of existing certifications.
• Together with manufacturers and suppliers, you will develop and optimize quality assurance programs and processes.
• You support customers with your expertise in Quality & Regulatory Affairs and develop suitable solutions together.
• You analyze quality-relevant key performance indicators and data and prepare meaningful reports for management.
• Working closely with research and development, you will support product validations, verifications, and the preparation of regulatory registration documents.

Your skills

• Ideally, you have a completed university degree or a comparable qualification.
• You already have several years of experience in quality management and/or regulatory affairs in the medical device industry.
• You are very familiar with the requirements of the Medical Device Regulation (MDR) and EN ISO 13485.
• You work in a structured, independent manner and with a high quality awareness.
• You are confident in your use of the common MS Office applications.
• Fluent German and English skills enable you to communicate professionally in an international environment.
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