We are MIETHKE, a globally active, medium-sized medical technology company based in Potsdam. As a technology leader in the field of neurosurgical implants, we develop and manufacture highly specialized solutions for the drainage of cerebrospinal fluid - with precision, innovative strength and responsibility for our patients suffering from hydrocephalus. Our particularly high level of vertical integration is a key success factor.

Quality is our top priority. As part of our Qualification & Validation team, you will be responsible for the implementation and maintenance of qualified devices, equipment, processes and computerized systems.

Be part of a diverse team: do you want to shape things, take on responsibility and work in an environment of equals? Then you've come to the right place. We are looking for a committed personality with analytical acumen, a structured way of thinking and a desire for responsibility.

And: diversity, appreciation and tolerance are part of our culture - we would be delighted if this also corresponds to your core values.

• You create risk analyses for manufacturing processes and the specific application of computerized systems.
• You will carry out qualification and validation activities for devices & systems, processes and computerized systems or software products.
• You will check maintenance documents to maintain the target condition of qualified machines and systems (incl. archiving of certificates).
• You will carry out supplier qualifications.
• You will be responsible for the administrative processing of non-conformities in the area of qualification/validation.
• You will be responsible for process optimization and process design as part of design changes and design transfers.

• Completed technical or scientific studies
• Initial professional experience in the medical tech
• ology or pharmaceutical sector ideally with a focus on computer system validation
• Knowledge of standards and guidelines from the medical technology sector such as DIN EN ISO 13485:2016 and DIN EN ISO 14971
• Knowledge of cleanrooms and their requirements according to ISO 14644 as well as sterilization of medical devices is desirable
• Experience in the GMP environment and basic knowledge of statistics are an advantage
• Very good written and spoken German and English skills and confident use of MS Office

• a working environment in an innovative, medium-sized company with over 250 employees and interesting and varied tasks
• family-friendly and flexible working time models, trust-based working hours and a workplace, where we can be ourselves
• an employment relationship initially limited to two years with a clear interest in a permanent contract in a secure economic situation
• the possibility of a company pension scheme, further qualification through the opportunity to participate in further training events
• sporting activities and team events as well as coffee specialties, tea and water at any time, but also much more