Job Title: QM-Manager (m/f/d)
Location: Heidelberg, Germany
Schedule: 1.0 FTE
Precisis is a well-funded startup, developing neuromodulation technologies focused on functional brain diseases, specifically epilepsy and neuropathic pain. Minimal invasiveness and precise targeting of stimulation therapy pose distinct advantages over currently available technologies in the market and are the foundation of Precisis projects. Our first product, the EASEE® System, is currently under clinical evaluation and will be launched in 2021.
The Precisis team of 15 consists of experienced and entrepreneurial-minded individuals with the common goal of bringing to the market next generation neuromodulation solutions.
• Executing the functions of quality management representative, data protection officer and occupational health and safety officer
• Preparation of the management review incl. proposal of quality objectives
• Moderation of the CAPA process
• Establishment and control of the audit program (internal, external and suppliers)
• Maintenance and improvement of quality assurance / quality control of the product realization processes
• Establishment and control of the program for product related market surveillance and assessment of regulatory changes
• Determination of the training need and control of the program for quality-relevant employee training
• Maintenance and improvement of the established quality management system according to the requirements of ISO 13485, MPEUAnpG / MPDG and MDR 2017/745/EU
• Analysis and improvement of processes
• Control of QM-related documents and records
• Academic degree with a scientific or technical focus or equivalent qualification
• 5 or more years of experience in the medical device industry (preferably active (implantable) medical devices or software for medical devices)
• Basic knowledge of product registration procedures for medical devices (EU/FDA)
• Good knowledge of standards and regulatory requirements (ISO 10993-1, ISO 13485, ISO 14971, ISO 62304, ISO 62366-1, MDR, MPEUAnpG / MPDG)
• Knowledge of 21CFR820 desirable
• Process oriented and solution focused personality
• Good written and oral communication skills in English and German
If you have any questions, please contact us at +49 6221 6559300.
Please send your collected application documents in pdf-form to email@example.com.