Telephone: 086 8395533
Quality Assurance Engineer
Our client, a medical device company in Galway are currently looking to recruit a Quality Assurance Engineer for their site.
The ideal candidate will be:
- Part of a cross functional team to complete an assessment and if required remediation of Spine Product Design and Process information
- A key team member in future acquisition & transfer projects to complete early gap assessments & remediation planning.
- Execute studies/validations (if required) to supplement the legacy design & process information & validations
- Ongoing sustaining design & process support to the Spine products including product improvements & supplier consolidation
- Initiate, develop and implement quality system improvements
- Provide guidance, direction and supervision to QA Technical Staff
- Bachelor's Degree in Engineering or equivalent; postgraduate in Quality Management preferable
- Ideally experience of Remediation of Design History Files in a Medical Device Environment
- Good working knowledge of quality systems and their application in a manufacturing environment
- Good working Knowledge of the Design & Design Control Process
- Experience of statistics and a good working knowledge of test method validation
- Working Knowledge of the requirements and application of ISO14971
- Good working knowledge of regulatory standards and industry practices
- Five (5)+ years' experience in a similar role / environment
Candidate should also have the following abilities/skills/qualities:
- Self-directed/starter: Ability to work under strict time constraints; meet deadlines with minimal guidance
- Leadership: Demonstrated ability to coach, assess, evaluate, develop, motivate and empower others.
- Time Management: Ability to prioritize, balance, and manage multiple efforts with strong results/goal orientation.
- Team player: Ability to work & communicate effectively as part of QA and cross functional / organisational teams
- Analytical: Passion for data, analysis, trends, reporting. Ability to write technical documentation
- Organisational Values: Demonstrate Customer First, Achieving Excellence, Developing People, Flexibility and Integrity in carrying out of all assigned responsibilities/tasks.
- PC Skills: Standard offices packages as well as ability to use customized computer software programs
For further information on this Quality Assurance Engineer role in Galway please contact Bimi Felix on 086 8395533 / email@example.com
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