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Qualification / Validation Specialist (m/w/d)
/ Validierungsthemen Vorstellung von Qualifizierungsdokumenten in Kunden- und Behördenaudits Sie bringen mit: Erfolgreich abgeschlossenes Studium der Fachrichtung Mechatronik, Maschinenbau, Elektrotechnik, oder einer vergleichbaren Studienrichtung Umfassende Fachkenntnisse der GxP-Regelwerke bezüglich Qualifizierung von Produktionsanlagen, Mediensystemen und Räumen Erfahrungen im GxP-Umfeld und vergleichbarer Funktion Hohes Verantwortungs-, Qualitätsbewusstsein und Eigeninitiative Selbstständigkeit und hohes Engagement Freude an der Arbeit im Team Deutsche Sprachkenntnisse in Wort und Schrift sind erforderlich, Englisch wäre von Vorteil Kenntnisse der aktuellen Good Manufacturing Practice (GMP) und regulatorischen Anforderungen in der Medizintechnik (ISO13485, MDSAP) Wir bieten: Unbefristeter Arbeitsvertrag Einen krisenfesten Arbeitsplatz mit attraktivem Einkommen Keine Schichtarbeit Flexible Arbeitszeitgestaltung Individuelle Mitarbeiterförderung und -weiterbildung Attraktives Paket an Gesundheits- und Sozialleistungen (z.Partner-Anzeige02.06.202455129 MainzIngenieur, Techniker -
1Tender requestsValue Stream and Development support activitiesExpert within cross-functional teams concerning EHS material compliance and biocompatibility questionsSupport in second source and material change projectsBiocompatibility / ToxicologySupport Development of biocompatibility evaluation strategiesPerformance of safety and risk assessments for medical devices, based on the used raw materials, on extractable and leachable chemicals or on biocompatibility studies (ISO 10993-17)Biocompatibility Evaluations and Toxicological Expert statementsProviding expert advice (e.g. expert statements)Acting as sponsor, study monitor and contact for chemical / biocompatibility studies in internal and external laboratories (creation of test plans and test reports)Compilation of overall biological safety assessment according to ISO 10993-1Secondary TasksSupport regulatory compliance, speed to market, reduction of risks to patients resulting in an increase in overall user satisfaction and enhanced regulatory compliance (as member of CFT or extended sub-teams)Support a Design Control approach and provide expertise to Value Streams and Q&R for compliance with applicable regulations (EU directive, local countries regulations)Close Collaboration regional as well as plant EHS departments and the central biocompatibility groupSupport Sustainability activities and internal and external auditsYour profileScientific background (Masters degree) in Toxicology, Chemistry, Biology or Material Sciences or related fieldsStrong background in chemistry of medical polymers and materials used in contact with blood and the related analytical methodsHigh identification with and loyalty to the department and the companyGood and professional relationship to and communication with international colleagues and superiorsHigh engagement on achieving the targets and on the objectives of the position, proactive and solution-oriented approach towards problems, ability to work cross-functional with all levels of employeesOrganizational capacity and analytical abilityAutonomy in decision-makingAbility for a cross-functional coordinationGeneral knowledge of medical device risk management and related regulationsGeneral knowledge of medical device regulations (NMPA regulation, MDD 93/42/EEC, MDR 2017/745, MDSAP etc.)General knowledge of applicable standards (e.g. ISO13485, ISO14971, ICH Q10, EU GMP, FDA 21 CFR § 820.250, etc.)Knowledge of internal and external processes and structures and of the (global) corporate Quality Management requirementsKnowledge in statistical methodsExperience in scientific writingEnglish (fluent, very good knowledge)Required: Office (Excel / Word / PowerPoint, Outlook, Teams) KnowledgeAdditional: SAP, PDM systems as PTC Windchill, FMEA toolsKnowledge of Medical Device field and application, Dialysis and related therapiesIndependent working structure, hands on and ‘can do’ mentalityAttitude to Team Work, ability to work in matrix environmentGlobal mindset approachYour contact Fresenius Medical Care Deutschland GmbHReference number R0150814 freseniusmedicalcare.comjobs.freseniusmedicalcare.com We welcome diversity At Fresenius Medical Care all job applicants are welcome – regardless of gender, age, origin, nationality, religion, disability, sexual identity and orientation, or any other personal characteristics.Partner-Anzeige17.05.2024Jobs, Karriere
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