Quality Specialist

The Team:An expanding company near Frankfurt that takes on the challenge of developing, manufacturing, and distributing innovative products to support therapy at home or in clinics.Responsibilities:Creating, updating, and/or reviewing process documents and technical documentationParticipating in problem-solving activities related to development, production, inspection, and testing, including CAPA, NCR, and supplier-related issuesParticipating in IQ/OQ and PQ activities, selecting test samples, validating test procedures, and risk management activities to ensure compliance with product quality standards and applicable regulationsMonitoring and controlling the nonconformity processOrganizing and managing quality control documentationSupporting internal and external audits and formulating responses to audit findings and CAPAsPreparing and reporting QC metrics during QMS reviewsTraining and supporting the production and service teams regarding procedures and quality policiesSupporting quality management in documenting and reporting KPIs for management reviewPlanning and conducting employee training (QA training)You Have:At least two years of experience with quality control procedures for the inspection and testing of electronic components, subassemblies, and finished products, or equivalent experiencePractical experience in the implementation and application of statistical methods in various areas of product realization, e.g., PFMEA, DFMEA, DOE, and GR&R methodsKnowledge of and experience working with a quality management system (QMS) in a regulated industryExperience in a medical device manufacturing environment and knowledge of ISO 13485 requirements are advantageousProfessional written and verbal communication skills in German and EnglishStrong presentation skills are desirableIndependent and efficient work style, eager to take on new responsibilitiesReliable team player with a proactive and independent work style and a practical approachWhat is in it for you:Pleasant working atmosphere in a modern, medium-sized companyComprehensive onboarding support from experienced colleaguesA varied and exciting work environmentA company culture that encourages contributing ideas and initiativeCustomer- and employee-oriented environment with flexible working hours