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Overview
Job Title: Engineer, Quality
Reports To: Associate Manager/ Manager/ Senior Manager, Quality Assurance
Position Summary
Provide quality engineering support and direction in quality assurance, control and preventative activities within operations and other business functions, with a focus on preventative measures and continuous improvement of products and processes. Advocate and lead the execution of initiatives & projects to enhance quality performance within the business. Ensure compliance to regulation and standards.
What Youll Do
* Work closely with operations and the business functions to ensure quality performance of product and processes.
* Oversight and approval of NC & CAPA, activist and mentor in problem solving and root causing activities.
* Lead and participate in the development and improvement of the manufacturing processes for existing and new products.
* Analysis and review of concession requests.
* Review and approval of change management activities.
* Maintain KPI for monitoring of process quality, perform analysis and interpret trends, take action as necessary.
* Support execution and analysis of QATs.
* Advocate of Human Factor practices, proficient in the science of Human Factor identification and mitigation.
* Proficient in risk management practices and tools, having high expertise in process risk. Develop and provide input for risk management by identifying opportunities and weaknesses.
* Proficiency in and makes continuous strides towards optimization of inspection methods and sampling. Support First Article Inspections.
* Proficiency in statistical methods and application.
* Participate and interface in internal & external audits with regulatory representatives, providing effective narrative and description of topic of expertise.
* Assist in the development, responsible for review & approval of process and equipment validation/qualification.
* Support manufacturing transfers to other plants/facilities, leading quality activities.
* Responsible for initiation, management and support of Ship, Product Holds, potential product escapes.
* Coach and mentor others in quality topics and activities.
What You'll Need
* Bachelors/Level 8 degree in Science or Engineering
* 0-2 years similar experience
* Keen eye for detail
* Strong communication skills
Location: Cork, County Cork, Ireland
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