Quality Engineer, Waterford

Based in our Waterford site and reporting directly to the Quality Manager, the Quality Engineer will act as a Quality point of contact for systems, processes, and quality activities within the site and will support the implementation and continuous improvement of quality systems in compliance with US and International regulations, laws, and guidelines.Responsibilities

Provide guidance and feedback on quality issues Lead customer complaint and quality investigations Work with relevant departments to ensure timely closure of actions Participate in supplier and regulatory audits Support manufacturing operations to ensure products are produced to specification and the validated state of the cleanroom is maintainedPerform critical and constructive review of procedures, processes and products Ensure equipment, systems, cleanrooms and products are always following applicable requirements Support technical transfer of products Own and manage relevant sections of the quality management system Support sterility assurance activities per relevant ISO standards and internal proceduresSupport bioburden and endotoxin programs Promote a Quality culture and encourage Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP) Lead internal audits and provide guidance on suitable actions Support other tasks as requested by the Quality Manager Qualifications

Minimum 3 years experience in a related role Third level qualification (degree in science, engineering or related discipline preferred) Experience working in a manufacturing environment, preferably pharmaceutical, bio-pharmaceutical or medical device industries Very good knowledge of GMP requirements in a regulated environmentTakes personal responsibility for their actions Self‑starter and able to work under minimum supervision Must have good communication and interpersonal skills to work in multidisciplinary teams Effective oral and written communication skills are essential to this role Benefits

Private Medical Insurance Company pension Serious Illness Income protection Life Insurance Company and personal performance related bonus plan/structure Continuous Professional Development supported through Training&Development

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