Design Control Specialist
- Tatabánya, Komárom-Esztergom
- Állandó
- Teljes munkaidő
- Lead design control and verification activities in collaboration with product specialists.
- Own the Design Input and Output process and documentation in SVS projects.
- Manage Product Risk Management processes and risk assessments, including standard compliance.
- Contribute to technical documentation such as test method rationales, product descriptions, and compositions.
- Support change requests and item specifications (SIC).
- Continuously improve procedures and systems related to risk management and design control.
- Degree in Engineering, Pharmaceutical Sciences, Chemistry, Biochemistry, or a related Life Science field.
- Experience in the medical device or life sciences industry, with solid knowledge of relevant legislation and quality systems.
- Strong English communication skills, both written and verbal.
- Proficiency in Microsoft Office.
- Knowledge of:
- Quality Management Systems & Processes
- Regulatory Standards (Advantage: EN ISO 13485, IEC/EN 62366-1:2015/A1:2020)
- Design Control & Validation
- Cross-functional strengths in:
- Business and Value Chain Understanding
- Self-Management and Critical Thinking
- Collaboration and Communication
Apply now and become part of a purpose-driven company that values quality, collaboration, and continuous improvement.Pursuing an ambitious growth agenda, Coloplast develops and markets products and services that make life easier for people with intimate healthcare needs. Employing about 16.000 people and with products available in more than 143 countries, we are one of the world´s leading medical device companies. We are constantly growing our business and always looking for new ways to move forward - we explore, learn and look for new ways of doing things.Coloplast is committed to being an inclusive organization, where people bring their differences to work each day, fulfil their potential and have a strong sense of belonging because - and not despite - of their differences. We therefore encourage all qualified candidates to apply regardless of gender, age, race, nationality, ethnicity, sexual orientation, religious belief or physical ability.Visit us on .Follow us on . Like us on .59248
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