Quality Assurance Lead for Medical Device Development
7 days ago
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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