Medical Device Design Quality Assurance Specialist
4 days ago
We're a leading Medical Device organization based in Dublin, offering exciting opportunities to join our team.
Job Description
We are currently recruiting for a Senior Design Quality Engineer to support new product design and development, working closely with Device Engineering through the entire product life cycle. This includes:
- Design control compliance ensuring consistent, workable and compliant planning, development, testing and change management.
- Regulatory compliance: ensuring product development (including software) and maintenance in accordance with FDA QSR's (21 CFR Part 820), ISO 13485, EU MDR, CMDR, MDD, J-PAL, IEC 62304 and relevant guidance documents.
- Design risk management, assuring appropriate and consistent risk management tool use i.e. FMEA, FTA, etc. for all programs and projects, compliant with regulatory standards (ISO/EN 14971) and industry practices.
Required Skills and Qualifications
To be successful in this role, you will need:
- Bachelor degree in science, microbiology, engineering or equivalent technical field with 8+ years of applicable industry experience or MS with 4+ years of applicable industry experience.
- Experience in medical device design control including software development and product realization.
- Competence in statistical tools including design of experiments and sampling methods.
- Experience in design quality assurance, risk management.
- Problem solving skills e.g root cause analysis and CAPA implementation.
- Understanding of one or more subsystem technologies: electrical, mechanical pneumatic and / or software systems.
- Understanding of human factors and user-interface design.
- Knowledge of medical device regulations including FDA, GMP, design controls, ISO 13485, EU MDR, IEC 62304, ISO 14971, etc.
Benefits
This is an excellent position for anyone looking to join a leading multinational who are one of the best at what they do. If interested in this posting, please feel free to contact us for further information.
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