Quality Engineer Systems (m/w/d) Auditis & DocCTRL

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 Systems, you ensure the effectiveness and conformity of our quality management system (QMS). Planning, coordinating audits and auditing internal processes and suppliers, responsible for document steering incl. DMS administration, design quality assurance agreements (QSV) with suppliers and advance the improvement of our QMS processes. 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.

Audit Management: Planning the Audit Year Programme (risk-based), Resource & Termine Coordination, Conducting Internal Process and Supplier Audits, Follow-up of Effectiveness Tests, Reporting Document steering & DMS: support of QMS documents (SOPs, work instructions, forms), examination of document changes, control of releases & review cycles, training of users:inside; Administration of the DMS/eTD incl. roles, metadata and change protocols QMS improvements: implementation of improvement measures, process mapping, key figures management and harmonisation of QMS processes Software/Tool support: Validation of quality-relevant software tools (e.g. DMS, eTD, test software) according to CSV/GAMP5; Maintenance of templates and checklists Supplier interface: Support for supplier qualifications (first samples, approvals) and creation and maintenance of quality assurance agreements (QSV); close cooperation with Purchasing, SQE, Development, Production and QM/RA Communication & Training: Contact person:in audit and document-related issues, performing internal trainings

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, You have already gained experience in the following areas: Quality management in regulated environments (e.g. ISO 13485, MDR, ISO 14971, 21 CFR 820) Quality Systems environment, in the supplier or QM auditing. Supplier Management (Qualification, QSV) Trusted with engineering practices of product development (e.g. requirements, design controls, FMEA).

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