We are supporting our medical device client who are looking to hire a Senior Design Assurance Engineer as their business grows.
This is a permanent role based in Galway which requires an onsite presence.
Key Responsibilities Lead quality activities including risk assessments, device testing, validations, audits, and technical documentation.
Manage Design History File (DHF) and support continuous improvement of the QMS.
Ensure product development and risk management activities comply with company procedures and regulatory requirements.
Translate user needs into design and manufacturing requirements, including test method development and process monitoring.
Conduct design verification, validation, and test method validation.
Collaborate with R