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.ResponsibilitiesProvide guidance and feedback on quality issuesLead customer complaint and quality investigationsWork with relevant departments to ensure timely closure of actionsParticipate in supplier and regulatory auditsSupport 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 productsEnsure equipment, systems, cleanrooms and products are always following applicable requirementsSupport technical transfer of productsOwn and manage relevant sections of the quality management systemSupport sterility assurance activities per relevant ISO standards and internal proceduresSupport bioburden and endotoxin programsPromote a Quality culture and encourage Good Manufacturing Practice (GMP) and Good Documentation Practice (GDP)Lead internal audits and provide guidance on suitable actionsSupport other tasks as requested by the Quality ManagerQualificationsMinimum 3 years experience in a related roleThird level qualification (degree in science, engineering or related discipline preferred)Experience working in a manufacturing environment, preferably pharmaceutical, bio-pharmaceutical or medical device industriesVery good knowledge of GMP requirements in a regulated environmentTakes personal responsibility for their actionsSelf‑starter and able to work under minimum supervisionMust have good communication and interpersonal skills to work in multidisciplinary teamsEffective oral and written communication skills are essential to this roleBenefitsPrivate Medical InsuranceCompany pensionSerious Illness Income protectionLife InsuranceCompany and personal performance related bonus plan/structureContinuous Professional Development supported through Training & Development
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