- Reference: AJ42340
- Job Type: Permanent
- Location: Galway, Leinster, Westmeath
- Category: Medical Devices
The QA Engineer will have responsibility for providing Quality support to processes, materials, and products. Assuring Quality standards are maintained and assist with the implementation of and compliance to, the Quality Management program.
Duties and Primary Responsibilities of the Quality Engineer:
- Complete new supplier evaluation and qualification.
- Liaises with suppliers to ensure drawings and specifications are clear, understood and fully compliant.
- Implement and improve metrics for supplier performance and incoming inspection
- Complete vendor audits
- Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instruction updates, and FMEA’s for any product line extensions, process improvements for new and existing products.
- Review and/or develop and execute facility, software, process and equipment validations and risk management documents.
- Review change controls for validation impact.
- Use knowledge of statistics to assist with validation developments and process improvements
- Provide quality support to Manufacturing Engineering with sampling plans, data processing or analysis for validation for new and existing product lines.
- Provide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.
- Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
- Perform Internal Audits.
The Quality Assurance Engineer will have:
- Degree in Engineering or Science(Level 8) is essential
- 4 years experience working in a similiar role
- Validation experience is essential
For a confidential discussion and a more detailed job description (or more information on the role), please contact Tina Egan on 09064 78104or email firstname.lastname@example.org
For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie
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