Design Assurance Engineer
A world leading Medical Devices company is seeking a Design Assurance Engineer to join their Galway based team.
Purpose
The Design Assurance Engineer will demonstrate commitment to the Quality Policy through sound quality practices and maintenance of an effective quality system.
Responsibilities
* Familiarity with medical device production and Design Control requirements
* Understanding of Design Assurance requirements for marketed products, product development, design changes, and technology transfers
* Interface 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 PIR resolution, complaints investigation, CAPAs, non-conforming product, VIPs, and regulatory requirement changes
* Support transition to EU MDR by collaborating with submissions, reviewing notified body feedback, and assisting divisional product teams with submission responses
* Provide detailed assessments of impacts for design and process changes on commercialized products
* Act as an inclusive team member in drawing conclusions and making decisions from test data
* Support internal and external audits and audit responses for commercialized and new products
* Collaborate in development and execution of Design Verification plans, protocols, and reports for new and commercialized products
Requirements
* NFQ Level 8 qualification in a STEM discipline
* Minimum 1-3 years experience in a Design Assurance capacity
* Good technical capabilities, communication skills, teamwork abilities, and initiative