Senior Quality Engineer
€40000 - €50000 per annum
Senior Quality Engineer
Our Client a leading medical device company in the west of Ireland are currently looking to recruit a Senior Quality Engineer to join their team.
- Be the Subject Matter Experts regarding Acceptable Quality Standards for products and processes.
- Organising, maintaining, and ensuring compliance to the company's documented quality management system.
- Creating procedures and ensuring effective implementation.
- Carry out internal audit and help facilitate external audit.
- Identify GMP non-compliance and assist in enforcing GMP's.
- Support the activities to ensure product quality complies with customer specifications through the production process
- The Operations Quality Engineer will perform an active role in further development and continuous improvement of the Quality Management system.
- Ensure all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed. (e.g. Use of DOE studies, FMEA's).
- Ensure Regulatory compliance in area of responsibility to cGMP's of all medical device regulatory agencies (e.g. FDA and TUV).
- Provide functional expertise to other support functions on quality related issues (e.g. regulatory requirements, statistical techniques, sampling principles).
The Ideal Candidate
- 3-5 years' experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.
- Excellent written and verbal communication skills
- Demonstrated ability to work with cross functional organisations in a dynamic manufacturing environment to solve problems
- Experience in the medical device industry
- Working knowledge and understanding of FDA, ISO13485, and the medical device industry quality requirements associated with manufacturing and supplier controls
- CAPA Experience
For further information on this Quality Engineer role in the West of Ireland please contact Orla Crowley /0830286256
Check out all our open jobs on our Wallace Myers International website https://www.wallacemyers.ie/jobs/search?sector=Life Science Engineering
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This position was pPosted on 06 Apr 2021