Design Assurance Engineer Our client a start-up company based in Galway currently seeks a Design Assurance Engineer to join their team. Role/Responsibilities: Provide design
Design Assurance Engineer
Our client a start-up company based in Galway currently seeks a Design Assurance Engineer to join their team.
- Provide design assurance input to Research and Development project teams for designated projects.
- Actively participate in specification development in relation to design input development.
- Working within the quality system and ensuring that the quality policy and company systems and procedures are complied with, in line with the Medical Device Directive and FDA Quality System Regulations 21 CFR Part 820.
- Identify change in systems or procedures, which could potentially affect compliance.
- Develop design verification and validation plans, protocols, and reports.
- Co-ordinate the design history file and risk management activities for designated projects.
- Provide direction to project teams and engineers in the processing and development of protocols, reports, procedures, deviations and change requests on a day-to-day basis for identified projects.
- Interpret new or existing quality/regulatory requirements as they relate to assigned projects.
- Review change control for designated projects for quality assurance implications.
- Minimum of 2 years relevant experience in the medical device industry.
- A diploma level qualification, or higher, in Engineering, Science, or related field is essential.
- Experience in medical devices or pharmaceutical industry is also essential
If you would like further Information you can contact the recruiter directly:James Cassidy | Tel: +353 (0) 1 5079250PLEASE APPLY DIRECTLY BY CLICKING HEREUnder the Data Protection Acts 1988 and 2003, your details will be kept confidential and will not be passed to a third party without your express prior consent.
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