Product Design Quality Assurance Specialist
4 days ago
We're a leading life science recruitment agency based in Dublin, Ireland. We specialize in matching top talent with exciting opportunities in the medical device industry.
Job Description
We're 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.
Key Responsibilities
- Support new product design and development, design transfer, design validation, design review, risk management, etc.
- Ensure design control compliance, including planning, development, testing, and change management.
- Collaborate with Device Engineering to ensure consistent, workable, and compliant processes throughout the product life cycle.
- Perform internal and supplier audits to maintain high-quality standards.
Required Skills and Qualifications
- 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.
Benefits
This is an excellent opportunity for anyone looking to join a leading multinational in the medical device industry. If you're passionate about quality assurance and have a strong background in medical device design control, we encourage you to apply.
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