Auf einen Blick
- Aufgaben: Unterstütze die Qualitätssicherung in der Medizintechnik und sorge für die Einhaltung von Vorschriften.
- Unternehmen: Innovatives Unternehmen in der Medizintechnik mit einem Fokus auf Qualität und Compliance.
- Vorteile: Attraktives Gehalt, Weiterbildungsmöglichkeiten und ein dynamisches Arbeitsumfeld.
- Weitere Informationen: Multidisziplinäres Team mit internationalen Kollegen und hervorragenden Entwicklungschancen.
- Warum dieser Job: Gestalte die Zukunft der Medizintechnik und arbeite an wichtigen Qualitätsprojekten.
- Qualifikationen: Abschluss in Ingenieurwissenschaften und Erfahrung in der Medizintechnik erforderlich.
Das prognostizierte Gehalt liegt zwischen 52200 - 63800 € pro Jahr.
- Support all quality development activities for commercial production
- Ensure compliance with internal procedures, FDA regulations, and applicable international standards including ISO 13485, EU MDR, and ASTM
- Serve as quality subject matter expert during regulatory and internal audits
- Support validation and re-validation of test methods and manufacturing processes
- Develop, review, and approve protocols and reports for test method validation
- Implement IQ, OQ, and PQ process qualification activities, including protocol and report review
- Collaborate cross-functionally with Manufacturing Engineering on design, production, and user FMEAs
- Create, maintain, and approve risk management documents in line with ISO 14971/24971
- Lead and support CAPA processes, including root cause analysis, problem-solving methodologies, and corrective/preventive action implementation
- Perform statistical analyses to determine process capability indicators using Minitab and DOE
- Support the Manufacturing Engineering team across quality-related tasks
Requirements
- Bachelor's degree in an engineering discipline, preferably Mechanical, Process, Materials Science, Chemical, or Pharmaceutical Engineering
- Experience in the medical device industry or a comparable regulated environment
- Practical knowledge of ISO 13485, ISO 14971/24971, EU MDR
- Hands-on experience with validation activities (IQ/OQ/PQ), statistical tools, and CAPA processes
- Fluent in German and English, written and spoken (mandatory)
- Strong analytical and problem-solving skills
- High level of accuracy and process-oriented working style
- Proficient in MS Office, especially Word
- Knowledge of DOE and Minitab statistical software
- Comfortable working in multidisciplinary, international teams
- Core Competencies
Demonstrates expertise in quality development activities, ensuring compliance with FDA regulations and international standards such as ISO 13485 and EU MDR.
Proficient in validation processes, statistical analysis, and risk management within the medical device industry.
- Highest-signal resume keywords
- ISO 13485 Compliance
- Validation Activities (IQ/OQ/PQ)
- Statistical Analysis (Minitab, DOE)
- CAPA Processes
- Fluent in German and English
- Hard Skills
- Quality Development
- Test Method Validation
- Process Qualification
- Root Cause Analysis
- Statistical Analysis
- Risk Management
- Problem-Solving Methodologies
- Regulatory Compliance
- Manufacturing Processes
- FMEA
- Soft Skills
- Analytical Skills
- Problem-Solving Skills
- Process-Oriented Working Style
- Collaboration
- Attention to Detail
- Industry Keywords
- Medical Device Industry
- FDA Regulations
- EU MDR
- Regulated Environment
- Tools & Technologies
- Minitab
- DOE
- MS Office (Word)
- #J-18808-Ljbffr
Quality Engineer – Validation, FMEA, Regulatory Compliance, Medical Devices Arbeitgeber: Jobtailor
Als Front Office Supervisor in unserem dynamischen Team bieten wir Ihnen die Möglichkeit, in einem unterstützenden und freundlichen Arbeitsumfeld zu wachsen. Wir legen großen Wert auf die berufliche Entwicklung unserer Mitarbeiter und bieten regelmäßige Schulungen sowie die Chance, Verantwortung zu übernehmen. Unsere Lage ermöglicht es Ihnen, Teil einer lebendigen Gemeinschaft zu sein, während Sie gleichzeitig die Standards unseres Franchise-Partners einhalten und unseren Gästen einen unvergesslichen Aufenthalt bieten.
