Documentation & Design Control Specialist (m/w/d) Medical Devices
vor 1 Woche
Vollzeit |Kundl
Are you an expert in your field, ready to apply your know-how to exciting projects?
Join the Hamburger TECCON Group, a team of over 450 professionals specializing in IT, engineering, and business. We develop innovative solutions for prestigious clients, aiming to discover and nurture human potential by creating tailored connections between companies and talents. Bring your expertise to our projects and actively shape the future.
Deine Aufgaben
- Documentation Excellence: Drive lean, compliant, and scientifically sound documentation processes by optimizing and digitalizing Design History Files (DHF) for efficient knowledge management.
- Cross-Functional Collaboration: Partner with R&D, Quality, and Regulatory teams to streamline technical development processes for faster and more effective product development.
- Data-Driven Process Improvement: Leverage data and analytics to identify opportunities for continuous improvement and support the digital transformation of documentation workflows.
- Regulatory Documentation Strategy: Collaborate with stakeholders to develop robust strategies and templates that ensure high-quality source documentation for Health Authority submissions.
- Smart Change Management: Advise and guide development teams on intelligent documentation and change control practices across projects, technologies, and functions; coordinate complex, cross-functional changes.
- Technical Documentation Authoring: Co-author new platform and pioneer project documents with Subject Matter Experts (SMEs) to establish clear, compliant, and innovative technical content.
- Clinical Evidence Documentation: Prepare and maintain Clinical Evidence Assessment documents that support regulatory and clinical validation requirements.
- Design Control Optimization: Support the creation and continuous improvement of Design Control procedures, ensuring alignment with global quality and compliance standards.
Dein Profil
- Education & Experience: Bachelor's, Master's, or PhD in Engineering or Natural Sciences with 3–5 years of relevant experience in Medical Devices, Quality, or R&D documentation.
- Regulatory Knowledge: Solid understanding and practical experience with EU Medical Device Regulation (MDR), ISO 13485, and US FDA regulations (21 CFR Part 4 and 21 CFR Part 820).
- Process & Quality Focus: Proven track record in improving development, documentation, or quality management processes (e.g. design control, document lifecycle management).
- Collaboration & Influence: Strong communicator and active listener with the ability to connect across global, cross-functional teams and drive alignment in a matrix organization.
- Analytical & Continuous Improvement Mindset: Passionate about structured problem-solving, process optimization, and digital innovation in documentation systems.
- Language Skills: Excellent command of English, both written and spoken; additional language skills (e.g. German) are an advantage.
Deine Benefits
- Exciting, self-organized and responsible tasks
- Long-term employment relationship, pleasant working atmosphere in a young, dedicated team
- Flexi time agreement, flexible working time model, work-life balance
- Opportunities for specialization and subject-specific further education and training
- Extremely collegial team with a friendly approach
- Various development opportunities within the TECCON Group
The gross annual salary is at least EUR but of course we offer overpayment in line with the market, depending on qualifications and professional experience.
Ihre Ansprechpartnerin
Renate Stefanowski
renate.-
TECCON Consulting GmbH
Am Tabor 36
1020 Wien
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Kundl, Österreich TECCON Consulting & Engineering GmbH VollzeitVollzeit |Kundl- Join the Hamburger TECCON Group, a team of over 450 professionals specializing in IT, engineering, and business. We develop innovative solutions for prestigious clients, aiming to discover and nurture human potential by creating tailored connections between companies and talents. Bring your expertise to our projects and actively shape the...
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