Head of Quality and Regulatory Affairs 100%

The Belimed Life Science AG with its headquarters in Sulgen (CH) operates as an independent stock corporation within the SteelcoBelimed Group. The internationally active SteelcoBelimed Life Science corporate group employs over 500 people worldwide and is one of the leading providers in the field of special machine construction for mechanical cleaning and sterilization in the areas of Life Science, Pharma, Biopharma, and Cosmetics. The SteelcoBelimed Life Science Group, together with the Business Units SteelcoBelimed Infection Control, employs more than 2200 people at 27 locations in Europe, America, and Asia. Looking for a job with hot steam and pure water? Then apply with us as: Head of Quality and Regulatory Affairs 100% (m/w/d) The Belimed Life Science AG with its headquarters in Sulgen (CH) operates as an independent stock corporation within the SteelcoBelimed Group. The internationally active SteelcoBelimed Life Science corporate group employs over 500 people worldwide and is one of the leading providers in the field of special machine construction for mechanical cleaning and sterilization in the areas of Life Science, Pharma, Biopharma, and Cosmetics. The SteelcoBelimed Life Science Group, together with the Business Units SteelcoBelimed Infection Control, employs more than 2200 people at 27 locations in Europe, America, and Asia. Looking for a job with hot steam and pure water? Then apply with us! Your tasks The Head of Quality is the direct contact person regarding the field of expertise they lead. You will implement and manage the quality processes as well as the management system of Belimed Life Science AG. You will ensure that the organization knows and complies with the requirements according to EN ISO 13485, ASME, DGRL, and the general GMP requirements according to FDA guidelines. You will be responsible for handling non-conforming products and complaints and coordinating corresponding corrective and preventive measures. Additionally, you will act as a contact person for quality management for customers and suppliers. The main tasks include: Implementation of the company strategy and goals Supporting the organization in implementing and managing the necessary quality processes. Definition of the certification strategy in cooperation with the CEO and coordination of the certification of the quality management system with the designated body. Ensuring that the organization is informed about Life Science GMP requirements such as material declaration and verification, GMP processes, FAT/SAT procedures, validation, etc. Supporting the organization in determining an appropriate training level according to customer needs. Ensuring the conformity of distributors and subcontractors, including certification, training levels, and regulatory compliance. Coordinating and handling deviations and investigations to ensure the effectiveness of corrective and preventive measures. Supporting customer complaint management. Evaluating the effectiveness of quality controls. Coordinating and obtaining pressure equipment approvals for new products and/or in new countries. Developing and reporting on required quality performance indicators (KPIs). Creating the management review for the management Acting as the main contact person for customers in quality-related matters (e.g., supplier questionnaires, audits); coordinating customer audits with suppliers of outsourced processes. Conducting internal and supplier audits (e.g., subcontractors). Defining, introducing, and revising company-specific quality documents and work instructions. Supporting the implementation of change requirements. Monitoring the implementation of 8D reports. Being the overall project manager for the introduction of quality software CAQ (Computer Aided Quality) The responsibilities include: Implementation and management of the quality management system of "Belimed Life Science AG" by the QM manager. Role of QA: decision-making on the release of FAT, delivery, concessions, and delivery stops. Collaboration with design for the release of type plates (e.g., test marks). Collaboration with the head of design for the creation of declarations of conformity. Leading the QA team in Sulgen, Grosuplje, and the USA. Your profile Bachelor's degree in (Electrical Engineering or Mechanical Engineering) German as mother tongue, English at advanced C1 level At least 5 years of relevant professional experience in the Life Sciences sector Proven, multi-year experience as a quality manager or in a leadership position within a quality assurance organization. Guidelines, regulations, and standards for Life Sciences, e.g., EN ISO 13485, ASME, DGRL, GMP, ... Technical expertise in regulations and standards in the field of pressure equipment, sterilization, and washing/disinfection technologies is desirable. MS Office (required), SAP or similar ERP systems (advantageous) Our offer With us, you can expect more than just a job – you will become part of a team that lives cohesion, development, and joy in work. We actively support you on your career path, promote your further education and language skills, and ensure a successful start with a department-wide induction and individual introduction plans. In addition to exciting tasks, you benefit from attractive benefits: discounted fitness subscriptions, free parking, discounts on Miele products, full salary during maternity and paternity leave, and 90 days of 100% salary continuation in case of accident or illness. And because success in a team is even more beautiful, we enjoy shared moments – whether over coffee or otherwise.