Prepare and approve specifications, sampling instructions, and quality control test instructions and ensure that they are followed
Perform product testing associated with process validation and series production, as well as assisting with design verification and aging tests
Ensuring that all required tests have been performed and in case of non-conforming test results, appropriate (OOS) investigation is carried out
Preparation of test reports
Releasing or rejecting components, packaging materials and intermediates used to manufacture the medical devices and combination products
Planning of laboratory capacities in coordination with plant management/production and development/project management
Coordination of test methods and work distribution with the laboratories at the other Haselmeier and medmix sites (for Haselmeier products)
Approval of commissioning as well as supervision of QC service providers (analytical laboratories, calibration service providers)
Ensuring qualification, calibration and maintenance of laboratory equipment
Planning and execution of test method validations, including either method development or method transfer from development
Proper, traceable storage and inventory control of laboratory materials and test samples, and ensuring that they are labeled, used, and disposed of in accordance with rules and regulations
Ensuring that occupational safety regulations are adhered to
By defining and monitoring target-oriented KPIs, ensuring that the throughput of tests and the associated costs remain on target while maintaining high quality, and that potential cost savings are identified and implemented.
What you offer
Professional training as a chemical or biological laboratory technician, metrology technician or comparable studies
Several years of practical experience in the testing and release of medical devices, their components and packaging materials or in the quality control of pharmaceuticals
Several years of working in a company with a QM system certified according to ISO 13485, ISO 17025 or GMP
Handling of and expert knowledge in the use of LIMS systems or software-supported measuring systems
Structured and planned way of working
High technical and social competence as well as the ability to inspire laboratory staff, lateral entrants, internal and external customers for the tasks and issues in the laboratory area
Very good knowledge of German and English, both written and spoken
Ideally already practical experience in the application of ISO 11608-1
What we offer
working in highly motivated, international teams
dedicated people who put the needs of patients at the center of their doing
attractive benefits and a flexible and modern working environment
Who we are
Haselmeier, a part of medmix, has been established in the healthcare marketplace for over 100 years. With approximately 250 employees, Haselmeier has been pioneering the development of injection pens for subcutaneous application since the 1960s. We continue to drive innovation in self-injection pens from design and manufacturing to packaging and delivery. We have developed solutions in scalable volumes for numerous pharmaceutical partners, always following state-of-the-art engineering practices – and we aim to evolve even further. We design our products with a patient-centric approach. Our injection devices are used in a variety of therapeutic areas, helping patients living with diabetes, supporting fertility treatment and even being an option for low-impact cancer therapy
Join us to impact the world of healthcare
If you are looking for an exciting job in a growing company with pleasant atmosphere and short distances, then apply!
