Design Assurance Specialist

3 days ago

Galway, Galway, Ireland beBeeQuality Full time €50,000 - €70,000
Design Quality Assurance Engineer Role

This role is a key part of our Design Quality Assurance team, responsible for ensuring the highest standards of quality are met in medical device design.

The successful candidate will be responsible for executing sound quality practices and maintaining an effective quality system. They will support the application of Design Controls in projects, initially supporting a Product Development Process (PDP) project.

The Design Quality Assurance team supports a wide product portfolio including drug-eluting therapies, balloon dilatation catheters, and cutting balloons for Interventional Cardiology. The successful candidate may work across projects to support quality, compliance, material continuity, and design Value Improvement Projects (VIPs), ensuring all design changes are compliant with regulations and procedures.

Key Responsibilities:
- Understand requirements and procedures that govern medical device Design Control.
- Ensure project deliverables comply with all internal and regulatory requirements related to Design Assurance.
- Develop and maintain the PDP Design History File, supporting design inputs, outputs, verification, validation, usability risk management, and design reviews.
- Support resolution of PIRs, CAPAs, NCEPs, and regulatory requirement changes.
- Interface with R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations teams to provide technical and quality systems input.
- Analyze test data to draw conclusions and make decisions.
- Manage design change projects, including scoping, assessment, and implementation.
- Update documents within the Risk Management File, such as Hazard Analysis, Task and Use Error Analysis, and Design FMEA.
- Maintain regulatory compliance with guidance documents like SOPs/WIs and EU/FDA/Global guidelines.
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.

Requirements:
- 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.
- Enthusiastic and motivated to develop their career, demonstrate best practices, and drive improvements in product and process quality.

About this Role:
This is an exciting opportunity for a highly skilled Design Quality Assurance Engineer to join our team and contribute to the development of innovative medical solutions.

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