Quality Engineer Operations (m/w/d) Validation of processes and software

Medical technology that changes life – since 1985 Stockert stands for innovation and safety in medical technology. Our systems improve the quality of life of millions – every day, worldwide. Do you want to use your previous experience to help shape innovative products in medical technology? We offer you the opportunity to take responsibility, to actively improve processes and to shape the future of medical technology in an interdisciplinary team. As Quality Engineer Operations, you are responsible for the quality and compliance of our production of active electrical medical devices. You ensure that processes, means of production and measuring systems meet the highest standards – and thus contribute directly to the safety of patients worldwide. With heart blood for a healthy future With passion, experience and a highly motivated team, we explore new technologies and develop medical devices that improve the everyday life of millions of patients and medical professionals around the world. Our name stands for advanced technology and high quality. For us there is no compromise when it comes to patient safety and customer satisfaction.

Responsibility for the Validation of Production Processes and Ensuring Quality & Compliance in the Product Development Process Planning and implementation of process and software validations (EU MDR 2017/745, 21 CFR 820.75, ISO 13485:2016, % F/IMDR, CSV/GAMP5) Execution of measurement system analyses (e.g. Cg, CgK, GR&R) at final inspection places Qualification and maintenance of production equipment and measuring instruments incl. Calibration and master data maintenance Continuous improvement of validation processes and maintenance and further development of the Master Validation Plan (MVP) Maintaining the validated state of outsourced manufacturing processes and support in the auditing of critical suppliers Working with the master data management in the ERP system for goods input and output processes Support for digitalisation of quality-relevant processes (ERP/DMS/eQMS)

Complete studies in medical technology, industrial engineering or a comparable technical discipline Joy of interdisciplinary work and the willingness to work in technical details Structured operation, clear communication and precise documentation Motivation to take responsibility and actively develop processes Ideally first experience in the following areas: Quality management in regulated environments (e.g. ISO 13485, MDR, ISO 14971, 21 CFR 820) Process and software validation (CSV/GAMP5) Statistical and quality tools (e.g. MSA, Excel) and common systems (ERP, DMS, eQMS) Methods and practices of product development (e.g. requirements, design controls, FMEA) Electronic measuring technology Quality Systems, supplier audits or QM audits

Very good German and good English skills We are also pleased to receive applications from candidates from the automotive industry – many of your competencies in the quality and process environment are directly transferable!

A safe workplace in a high-growth and crisis-proof industry where you actively contribute to improving the lives of many people Great design spaces and the opportunity to work in an interdisciplinary and international team Individual training and development plans tailored to your talents A corporate culture characterized by appreciation, open communication, flat hierarchies and short decision paths Attractive benefits and flexible work models that fit your life JOBV1_EN