Design Quality Engineer
Our client, a medical device company in Galway are currently looking to recruit a Design Quality Engineer for their site.
Key Responsibilities of the Role
- Product Definition - Work with R&D, Marketing & Commercial teams on the full end-to-end product definition
- Quality Design Control Deliverables - Participates in project teams to review and develop clear and concise user requirements, verification and validation studies, risk analysis, test plans, control plans and product specifications
- Risk Analysis - Work with R&D and GE on Design FMEA during development and industrialization of new products
- Control plans - Owner for product characteristic controls in control plans and define critical to quality(CTQ) product characteristics in association with GE
- Downstream validations - Work with downstream partners on validations to ensure controls in place to deliver customer and regulatory requirements
- Validate new raw material suppliers - Support the definition & control of process inputs including supplier & raw material controls, QA testing & process Control Plans
- Fit-for-use analytical methods - Work with R&D to develop and validate analytical methods and specifications to qualify products in line with customer requirements and product claims
- Trouble-shooting focus - Lead problem solving and C.I focus to reduce variation during the development & industrialization phases and as part of the hand-off to the pilot site
- Hand-shake with pilot sites - Ensure that there is a formal hand-over of quality processes and deliverables to pilot sites & other sites processing Transitions products
- NPDP optimisation - Support the continuous improvement of the New Product Development Process, e.g. definition of the deliverables for hand-off between Stages
- Reporting & Documentation - Prepare and present summary documents / presentations of the validation testing results for senior management. Maintain records & documentation that support the One Quality validation process
- Bachelor degree, or higher, in an engineering or science discipline
- 8 to 10 years’ experience in a high volume manufacturing facility with strong quality assurance discipline
- Experience of FMEA, control plan development, Statistical Process Control (SPC) and capability analysis
- Solves problems through the application of appropriate scientific, experimental, and statistical methods. Application of Six Sigma and similar methods for reducing variation and improving process knowledge.
- Intellectually sharp, capable and can conceptualize systems and solutions. Pursues improvement projects with energy, drive and a need to finish.
- Proficient in Microsoft Office applications (e.g., Word, PowerPoint, Excel, and Access)
- Strong presentation skills, utilizing tools to address opportunities for improvement and experience in providing reports and data analysis to a variety of audiences.
- Customer focus
- Drive for results
- Personal learning
- Interpersonal savvy
- Managerial courage
- APQP or DFSS experience
- Black Belt in Six Sigma
- Proficient in the use of JMP statistical software
- Analytical chemistry or experience in developing specifications for raw materials
For further information on this Design Quality Engineer role in Galway please contact Bimi Felix on 086 8395533 / email@example.com
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