Quality Product Development Specialist
5 days ago
We are seeking a skilled Design Assurance Engineer to join our team. This role is ideal for an individual who is passionate about ensuring product quality and safety.
The successful candidate will have a strong technical background in a STEM discipline, with experience in design control, risk management, and regulatory compliance.
Key Responsibilities:- Develop and maintain the Design History File, including design inputs, outputs, verification, validation, usability risk management, and design reviews.
- Ensure project deliverables comply with all internal and regulatory requirements related to Design Assurance.
- Analyze test data to draw conclusions and make decisions.
- Manage design change projects, including scoping, assessment, and implementation.
- Maintain regulatory compliance with guidance documents like SOPs/WIs and EU/FDA/Global guidelines.
- NFQ Level 8 qualification in a STEM discipline.
- Minimum 3 years of industry experience; Design Assurance experience is an advantage.
- Experience in new product development, design control, risk management, design change, and standards compliance.
- Strong technical, communication, and collaboration skills; ability to adapt across projects.
- Proven ability to work well in teams and independently.
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