Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases. As a global health care company, we have
a special goal: provide the best possible care. Join us to improve the quality of life for a growing number of patients around the world and be a vital part of our team.
…+ <- german-wide / Bayern · Permanent · Full-time · As of now Design Quality Assurance Expert (m/f/d) In your role as Design Quality Assurance Expert (m/f/d) you will be responsible for ensuring the quality of design control activities for Active Medical Devices, supporting the project design and development to correctly realizing product development processes and complying with all specific requirements and applicable standards. Your assignments Ensuring that all design control deliverables comply with applicable regulatory requirements and design controls SOPs Providing input and guidance to design and development and design changes; thereby taking accountability for quality compliance as a member of the cross-functional project team Preparing design and development documentation for project and for design control activities together with Project Managers Supporting the creation of DHF needed for Medical Device Compliance Assisting Regulatory Affairs team to complete Technical Dossier / Registration Dossier Providing training on design and development of relevant quality requirements (regulatory requirements and SOPs) Reviewing and approving all product development and Design Change projects in compliance with Quality Management System requirements Quality Approver for Design and Development related NC / CAPAs Internal and external audit support of design & development matters Your profile Successful completed bachelor's or master's degree At least 3 years professional experience in research and development, regulatory affairs or quality management for medical devices or pharmaceuticals Advanced knowledge of medical device regulations (MDD 93/42/EEC, MDR 745/2017, MDSAP, NMPA regulation, etc.) as well as applicable quality management and risk management standards (e.g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CDR § 820.250, etc.) Knowledge of CAPA methodology Basic Knowledge in statistical methods Good knowledge of MS Office, ideally further knowledge of QTRAK, PLM systems as PTC Windchill, FMEA tools Good and professional communication skills to interact with internal and external partners Global thinking, intercultural competence Good knowledge in written and spoken English and German (minimum B2 Level) Apply now Share this job Print this Page Your Contact Saskia Derleth VIVONIC GmbH VIVONIC GmbH Ref. number 56545 At a glance Career level: Professional Experienced Job category: Quality Management / Environment Working condition: Permanent / Full-time Business segment: Fresenius Medical Care Location: german-wide / Bayern Closing date for application: none - we look forward to your application More information Information about the application process Our offer at a glance «The questions that take top priority in our work are how to best listen to our patients' voice, recognize their needs and gear our processes towards them. It's a very fulfilling role.« Sandra Löber Program Manager Medical Sustainability, Fresenius Medical Care Fresenius Medical Care - Creating a future worth living. For patients. Worldwide. Every day. More than four decades of experience in dialysis, innovative research, the global leader in dialysis services and products - that is Fresenius Medical Care. freseniusmedicalcare.com We welcome diversity At Fresenius all job applicants are welcome - regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics. All terms used in this job advertisement to denote persons refer to all genders equally (male, female, diverse). #careerswithapurpose at Fresenius Over 300,000 people across the globe work at Fresenius to provide better ever medicine for ever more people. Our independent business segments Fresenius Medical Care, Fresenius Kabi, Fresenius Helios and Fresenius Vamed offer a wide spectrum of products and services in the health sector. We offer you the opportunity to make a difference with your career - and to become part of our impressive growth story. Vivonic GmbH https://files.relaxx.center/kcenter-google-postings/kc-18317/logo_google_medicalcare.png 2023-07-15T10:36:16.519Z FULL_TIME null null null 2023-05-16 Bundesweit 51.165691 10.451526