QA Engineer

Westmeath  ‐ Onsite
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Keywords

Description

I have an immediate opening for Quality Assurance Engineer with my client, a leading Medical Device company based in Athlone. The successful candidate 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 and for supporting company goals, objectives, policies, procedures, quality systems and compliance with regulatory requirements (ISO, FDA, JPAL and other agencies as applicable).

Requirements
- 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
- Experienced in writing protocols, familiar with quality systems and assisting with root cause investigatio0ns.

Manufacturing Quality
- 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.

Education:
Degree in Engineering or Science or minimum 5 years experience in a Medical Device environment.

Experience:Five (5) years experience working in a regulated environments, specifically medical device, FDA or ISO 13485 registered work environments.

This is an excellent opportunity to join a growing company that is offering a very competitive salary of €45,000-€50,000 plus benefits. You will gain hand on experience working on new product transfers.

If you are interested in this position please apply now or contact me Derek Sheridan on for further detail.

To find out more about Real please visit www.realstaffing.com
Start date
08/2013
Duration
Permanent
From
Real Staffing
Published at
30.07.2013
Project ID:
573808
Contract type
Permanent
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