Design Assurance Engineer
We are seeking a highly skilled Design Assurance Engineer to join our team in Galway.
Purpose:
Demonstrate commitment to the Quality Policy through sound quality practices and effective quality system maintenance.
Responsibilities:
* Familiarity with medical device production and Design Control requirements.
* Understanding of Design Assurance requirements for marketed product development, design changes, and technology transfers.
* Interfaces with Operations teams, R&D, Regulatory Affairs, Clinical, Medical Safety, Complaints Management Centres, and Post Market Quality Assurance team environment.
* Provide design quality support and product assembly knowledge in the resolution of PIRs, complaints investigation, CAPAs, non-conforming product, VIPs, and regulatory requirement changes.
Key Skills:
* NFQ Level 8 qualification in a STEM discipline (Science, Engineering).
* Minimum 1-3 years experience in a Design Assurance capacity.
* Good technical capabilities, communication skills, teamwork abilities, and initiative.
This role offers excellent career progression opportunities and the chance to work with a world-leading Medical Devices company.