- Reference: AJ42340
- Job Type: Permanent
- Location: Galway, Leinster, Westmeath
- Category: Medical Devices
Quality Engineer-Our Client a leading Medical Device Manufacturer in the Midlands are currently seeking a Quality Engineer on a permanent basis to lead and assist in product transfer projects from sister sites in the US.
The Quality Engineer will report to the Quality Manager and will be responsible 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.
- Assist in the analysis and resolution of problems that may reduce the efficient running of production 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.
- Assist in the development, analysis and improvement of site Quality Metrics.
- Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
- Will comply with all relevant training required and adhere to relevant associated documentation.
- Follow strict adherence to the requirements of CGMP.
- Actively contribute to the enhancement of compliance initiatives for areas of responsibility.
The Quality Assurance Engineer will have:
- Degree in Engineering or Science(Level 8) is essential
- 4 years experience working in a similiar role
- Experience in Product Transfers
- Experience in project management
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
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