Design Assurance Engineer – Galway
Design Assurance Engineer required by a market leading Medical Device multinational based in Galway.
- Participates in new product development and leads.
- Executes the project design plans, protocols.
- Partner with R&D and Process Engineers to ensure that the transition of products.
- Liase with R&D, Operations & Customers in the development, customization and control of product labelling.
- Defines and implements quality standards and specifications and helps to ensure that regulatory requirements are met.
- Develops and executes required validations in line with regulatory standards.
- Promotes compliance and excellence within the company.
- Conducts audits, including closing out audit findings.
- Creates and maintains company quality documentation.
- Conducts root cause analysis and implements corrective action.
- BSc. in Engineering or Quality.
- 3+ years as a Design Assurance Engineer within a Medical Device or regulated environment.
- Strong working knowledge of the product development process within the medical device industry.
- Detailed knowledge of the regulatory environment.
- Ability to support and lead DA activities on multiple projects simultaneously.
- Strong technical writing and verbal communication skills.
- Attention to detail while maintaining awareness of longer-term objectives.
- Capacity to maintain the highest levels of confidentiality internally and externally.
- Must be authorised to work in Ireland.
Please contact Emer Moore to discuss in confidence