Senior Design Quality Engineer, Best, Noord-Brabant

The Company
The company combines cutting-edge engineering with design excellence to bring high-quality, user-focused devices to the market. Collaboration, creativity, and continuous improvement form the foundation of their culture.

Role Description
As a Senior Design Quality Engineer, you will lead quality and reliability initiatives for IGT Systems medical products. You will ensure that innovative products meet the highest standards of safety, performance, and reliability, while coaching project teams and guiding cross-functional stakeholders in all aspects of Design Control and quality engineering.

Responsibilities
- Define and manage holistic patient and user safety, quality, and reliability strategies for products
- Develop and validate Quality Plans covering all stages of the product lifecycle
- Lead quality-related problem solving and risk management activities
- Collaborate with post-market teams to translate field learnings into design and process improvements
- Integrate requirements engineering, CTS, and CTQ flow-down activities into product development
- Review DHF/DMR documents and ensure robust documentation for verification and validation

Requirements
- Bachelor’s degree with 12+ years or Master’s with 8+ years in Quality/Reliability Engineering (medical or aerospace preferred)
- Knowledge of global medical device regulations (21CFR820, ISO13485, EU MDR, IEC60601, IEC62366, ISO14971) is a plus
- Experience in Risk Management, FMEA, Design Controls, Verification & Validation, and Systems Engineering methodologies
- Strong exposure to R&D product development processes
- Effective communication, stakeholder management, and project management skills

Other Information
If you are passionate about ensuring product safety and reliability, thrive in high-tech environments, and want to make a tangible impact on patient lives, we’d love to hear from you.

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