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Quality Engineer
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Full Time
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Remote
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Cork
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41822468
Job Summary:
Plans and conducts activities concerned with the quality control and quality assurance of products manufactured in cleanrooms under ISO 9001:2015
*Essential Job Duties:
- Work as part of a value stream to ensure appropriate quality oversight and support to operations
- Drive continuous improvement and embed a culture of quality to ensure ongoing compliance with ISO9001:2015 standards
- Troubleshoot complex problems as part of a cross functional value stream
- Ensure the QMS is in place, in use and aligned to current regulatory expectations
- Design and implement test plans and audits for products to ensure product quality targets are met
- Establish, define, implement, maintain, and report on quality assurance key performance measures and standards
- Investigate non-conformances and consumer complaints, perform root cause analysis, implement corrective actions, and monitor progress and improvements
- Create and maintain quality systems documentation, such as quality manuals, procedures, and work instructions
- Perform quality assurance and qualification audits on vendors/suppliers
- Participate in and host customer audits of the facility
- Devises sampling procedures, design and develop forms and instructions for recording, evaluating, and reporting quality data
- Write technical reports
- Coach and support others in relation to quality best practices as required
Qualifications:
- Bachelor of degree in Engineering, Science or equivalent
- 4+ years of experience working in a regulated environment (ISO accredited, Pharmaceutical, medical devices etc.)
- Familiarity with cleanroom manufacturing
- Working knowledge of Microsoft Office applications
- Experience in general quality systems (internal and external audits, CAPA management, customer complaints handling, non-conformance management etc.)
- Ability to articulate complex problems in a clear concise manner through effective communications and technical report writing skills
- Strong analytical problem solving skills
- Demonstrated ability to work collaboratively as part of a cross functional team
Interested candidate shsould submit an up to date CV to be considered for the role or contact Sean on 0214297900 or Sean.Barron@peglobal.net