Senior Quality Engineer – Limerick
Working as part of the Design Assurance team you will be required to support the product throughout it’s entire life cycle from inception to launch.
- Design Assurance Quality Engineer on project core teams for design change projects.
- Responsible for product quality, DHF documentation, compliance, patient safety, customer satisfaction.
- Generate test protocols based on specification requirements.
- Perform statistical analysis of results.
- Review quality objectives and ensure they are sufficiently defined in specifications, procedures, and testing.
- Guides the successful completion of major programs and may function in a project leadership role.
- Provides management with review opportunities at key points.
- Ensures quality conduct of projects, including design, data summary and others.
- Implements and communicates the strategic and technical direction for the product/project team.
- Identifies any issues that may delay product or project and recommends appropriate action to be taken.
- BSc. in Engineering required or related discipline.
- 5-7 years of medical device quality engineering experience.
- Expertise in design assurance including design controls.
- Embedded software validation experience advantageous.
- Capital Equipment validation advantageous.
- Experience with Risk Management advantageous.
- Ability to act as Change Agent.
- Experience working with cross-functional teams.
- Previous experience working in a regulated FDA industry.
- Must be authorised to work in Ireland.
Please contact Emer Smith to discuss in confidence