We are seeking an experienced Quality Assurance Engineer to join our team in a permanent role.
The successful candidate will play a key role in ensuring the quality and safety of medical devices by implementing effective quality practices and maintaining a robust quality system.
Key responsibilities include:
* Understanding and implementing Design Control requirements to ensure project deliverables meet internal and regulatory standards.
* Developing and maintaining the Product Development Process (PDP) Design History File, including design inputs, design outputs, design verification, design validation, useability risk management, and design reviews.
* Providing design quality support in resolving product issues, nonconforming products, and regulatory requirement changes.
* Collaborating with cross-functional teams, including R&D, Regulatory Affairs, Clinical Risk, Medical Safety, and Operations.
* Using analytical and problem-solving skills to draw conclusions from test data and make informed decisions.
Required qualifications include:
* National Framework Qualifications (NFQ) Level 8 qualification in a STEM discipline.
* Minimum 3 years of industry experience, preferably in Quality Assurance.
* Experience in areas such as new product development, design control, risk management, design change, and standards compliance would be advantageous.
As a Quality Assurance Engineer, you will have the opportunity to work on a diverse portfolio of products and projects, driving quality and compliance while fostering innovation and collaboration.
Our ideal candidate is a motivated and detail-oriented individual who thrives in a fast-paced environment and is committed to delivering exceptional results.