Quality Assurance Lead for Medical Device Development

7 days ago


Dublin, Dublin City, Ireland Life Science Recruitment Full time
Medical Device Design Control Expert
We are seeking an experienced Senior Design Quality Engineer to join our client's team. As a key member of the quality organization, you will play a vital role in ensuring the design and development of medical devices meet the highest standards of quality, safety, and regulatory compliance.

Responsibilities
- Support new product design and development, design transfer, design validation, design review, risk management, etc.
- Design control compliance: ensuring consistent, workable, and compliant processes throughout the product life cycle.
- Collaborate with Device Engineering to ensure high-quality standards are maintained throughout the product life cycle.

Requirements
- Bachelor's degree in science, microbiology, engineering, or equivalent technical field with 8+ years of experience in medical device design control.
- Experience in software development, product realization, and statistical tools, including design of experiments and sampling methods.
- Strong understanding of human factors and user-interface design, as well as knowledge of medical device regulations (FDA, GMP, design controls, ISO 13485, EU MDR, IEC 62304, ISO 14971).
- Lead auditor certification and experience in supplier management.

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