Job Description:
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We are seeking a highly skilled Operations Quality Engineer to join our team. In this role, you will be responsible for ensuring the quality and compliance of our products and processes.
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Your primary focus will be on analyzing quality standards, applying measures, sampling methods, testing methodology, and other procedures to ensure that quality standards are met.
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You will provide quality expertise and guidance to manufacturing/operations, technical/product test, and incoming materials to support the manufacture and delivery of quality and compliant products on time, in full, and cost-effectively.
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This is a shift-based role on a 4-cycle shift schedule.
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Key Responsibilities:
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* Apply quality principles, analyze quality records, prepare reports, and recommend improvements.
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* Conduct inspection, verification, and validation of components or materials used in development processes.
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* Identify and address recurring problems either with the quality of the product or the reliability of testing procedures.
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* Document quality issues and performance measures for management review.
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* Liaise with external vendors as necessary.
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* Monitor and maintain the validation status of site products, processes, and systems and monitor and maintain process FMEA and Critical Quality Attribute systems.
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* Maintain site validation plans and periodic review process. Support equipment and software validation activities and support process validation activities.
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* Provide regular updates to peers and colleagues on project resource requirements and ensure other quality functions are brought into project teams at appropriate points.
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* Report on and support the implementation of actions to reduce the occurrence/reoccurrence of non-conformances within manufacturing, product test, and incoming material and initiating exception reports for discrepancies observed during inspection/testing & review activities.
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* Present and communicate status, report metrics, identify trends, potential issues, improvement initiatives, and CAPA requirements.
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* Investigate customer complaints and forward reports to PQA group and responsible for maintaining Corrective and Preventive Action programs.
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* Responsible for maintaining an appropriate balance of quality, compliance, and business risk and responsible for ensuring teams use appropriate risk management tools to prioritize certain activities and justify the level of effort required.
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* Monitor and maintain the quality and compliance status of associated quality records and ensure project teams maintain project records in compliance with Quality System and planned requirements.
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* Support DMR change control and calibration activities.
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Qualifications and Experience:
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Minimum NFQ Level 7 qualification in Engineering or Manufacturing qualification
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3 years experience in a Manufacturing / Science or Engineering environment
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GMP/GDP experience
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ISO 13485 experience
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Yellow belt qualification desired
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What We Offer:
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Attractive compensation package that includes competitive pay, as well as benefits such as family health insurance, excellent pension scheme, life assurance, career development, and fantastic new facility.
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Growing business plus access to many more benefits.
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