Quality Manager & Auditor

Quality Manager & Auditor (w/m) You are looking for an exciting professional challenge in a dynamic and growing company in the field of orthopedics? Then you are right with us! We are an American-Swiss company that has specialized in the development and manufacture of innovative orthopedic products. Our established products enable patients to be more mobile and thus improve their quality of life. Quality Manager & Auditor (w/m) 100%, permanent position We are looking for a committed and networked thinking personality who actively develops and sustainably strengthens our audit processes in the area of internal audits and supplier audits. In this role, you will shape the planning and implementation of system and process audits at our locations and with suppliers and make a significant contribution to effectively implementing the regulatory requirements for our quality management system in everyday life. What you can achieve As a process owner, you will continuously develop the internal audit process and the supplier audit process and adapt them to the current requirements of the organization. You ensure that regulatory requirements are met and effectively implemented in practice. You create the annual audit planning and ensure reliable implementation across all locations. You plan and conduct internal audits at our production sites and accompany the sustainable implementation of the resulting measures in the QM system. You regularly conduct supplier audits and ensure that identified non-conformities are effectively addressed. You support and coach auditors in planning, conducting, and reporting their audits. You keep an overview of audit non-conformities, derive relevant key figures, and drive the consistent implementation of improvement measures. You take on projects in the quality environment and work closely with various departments and international production sites. You accompany audits and inspections by certification bodies, notified bodies, authorities, and customers. What you bring You have a technical basic education, for example as a mechanic or designer, supplemented by further training in quality and audit management. You have several years of experience in auditing process-oriented and risk-based quality management systems in a regulated environment such as medical technology or pharmaceuticals. You have in-depth knowledge of the relevant regulatory requirements such as ISO 13485, 21 CFR Part 820, cGMP or MDSAP. You are able to quickly grasp processes, present them in a structured way, and recognize relationships. You have experience in handling CAQ systems such as CAQ AG Factory Systems or Oracle Agile PLM and work safely with MS Office. You are characterized by a self-dependent, structured, and analytical way of working. You have very good German and English language skills in word and writing and use them in a target group-oriented manner. You are willing to travel around 30 percent, whereby these deployments can be planned individually. Your perspective You can expect a varied and exciting task in the growth market of medical technology, which you can help shape as a technically skilled, committed, and initiative personality. Enovis is a worldwide leading company in the field of orthopedic and medical technology. As a traditionally American-Swiss orthopedic company with international production and development sites, we focus on the development, manufacture, and distribution of endoprosthetic solutions in orthopedics. In 2021, Mathys and Enovis merged to strengthen their position in the growing market for artificial joints. Kristiana Senior Human Resources Manager