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Quality Engineer

Quality & Laboratory
Cork
Siobhán Lane
Permanent
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Job Reference: JO-2008-65355_1598456084

Summary:


Responsibilities:


* 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



Requirements:


* Bachelor of degree in Engineering, Science or equivalent


* 5 + 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


* Ability to communicate effectively at all levels of the organisation




Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


Fastnet - The Talent Group
'Not Just Placers.........Partners'


The Life Science Specialists


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Siobhán Lane
Siobhán Lane
Talent Consultant
Quality & Laboratory
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