Design Assurance Engineer Galway
This DA Engineer Job in Galway is a permanent job. Our client a leading medical device company requires a Design Assurance Engineer who is interested in gaining valuable experience and career progression opportunities.
Key Responsibilities of Design Assurance Engineer Job
- Interfaces with R&D, Regulatory Affairs, Clinical Marketing, Process Development and Manufacturing in a project team environment providing technical and Quality systems input to the team.
- Seeks to support improvements in product and process quality
- Builds Quality into all aspects of work by maintaining compliance to all quality requirements. Participate in internal audit program.
- Provides both quality and technical input to the design reviews, project development/ design change/recertification plans, risk management, design verification/validation protocols and reports, for new development projects as well as design/process changes to existing product lines.
- Responsible for the compilation of design verification/validation protocols, reports and design/quality documentation supporting product development/sustaining engineering projects. Participates in Simulated Use/Bench Testing as part of both early development projects and during execution of design verification/validation studies.
- Provides design quality support in the resolution of PIRs, complaints investigation, CAPAs, VIPs, regulatory requirement changes.
- Updates Quality policies to ensure compliance with Product Development needs and relay this information to the Product Development Group.
Education, Experience and Skills
- HETCA Level 8 Education in a relevant area with a minimum of 2 years' experience in a similar environment.
- Good technical capabilities, communication skills, teamwork abilities and initiative.
- Proven ability to work well as part of a team & on own with minimum supervision
- Excellent analytical and problem solving abilities
- Experience in validation techniques, risk management, statistical techniques and compliance to regulatory requirements.
For further information on this Galway Design Assurance Engineer role or any other Design Assurance Engineering jobs please contact Cliona O?Malley on 091730022 / firstname.lastname@example.org
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