Social network you want to login/join with:This is a 23 month fixed term contract based in Carrigtwohill.Position Summary:Provide quality engineering support in quality assurance, control, and preventative activities with a focus on continuous improvement of internal products and processes. Support supplier quality issues impacting daily operations. Advocate and lead the execution of initiatives and projects to enhance quality performance within the business and for our customers. Mentor and provide technical direction across multiple areas of expertise. Ensure compliance to regulation and standards.General Requirements:Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) desiredUnderstanding of US and International Medical Device RegulationsFamiliarity with ISO 13485, GDP, GMP requiredStrong knowledge of Quality concepts (e.g. Risk Management, CAPA, Audits, Statistics)Must possess strong communication, project management and influencing skills as well as have the ability to manage multiple tasks simultaneouslyAbility to represent Quality function within and across the project teamsStrong interpersonal skills, written, oral communication and negotiation skillsStrong in critical thinking and outside the box thinkingHighly developed problem-solving skills,Strong analytical skillsDemonstrated ability to successfully manage and complete projects in a matrix organisationDemonstrated ability to work independently and as part of cross functional teamsExperience in working in a compliance risk situationPrevious industry experience requiredSome travel may be requiredKey Areas of Responsibility :Work closely with operations and the business functions to ensure quality performance of product and processesCollaborates with Divisional QA, cross functional and suppliers’ teams to address top quality issuesOwn identified internal and supplier non-conformances and manage the timely closure of NC’sOwn or support identified internal CAPAs and manage to timely root cause investigation, implementation and closureDisposition non-conforming product within MRB, issuing NCs as appropriateCommunicate and collaborate with suppliers regarding non-conformances, escalating supplier corrective actions requested as requiredEngage in the development and improvement of internal manufacturing processes for existing productsPerforms critical assessment of internal and supplier proposed change management activitiesPerforms PPAP activities for supplier changesParticipates and may lead in the creation and/or review of new or modified proceduresMaintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating on appropriate actions as necessarySupport execution and analysis of manufacturing related complaints and product field actionsSupport and drive Human factor practices, familiarity in the science of Human Factor identification, reduction and mitigationCollaborate with appropriate stakeholders to identify and execute opportunities for supplier part certificationDevelop understanding of risk management practices and concepts and applies knowledge to manufacturing operations.Support the creation and maintenance of inspection methods and sampling.Applies statistical methods of analysis and process control to current operations.Engage and interface in internal and external audits providing subject matter expertiseSupport the development and review of process and equipment validation/qualification and MSA of internal processes.Execute internal quality deliverables associated with engineering changes, manufacturing transfers and supplier-initiated changes.Support manufacturing transfers to/from other plants/facilities, executing appropriate quality activities.Responsible for initiation, internal containment, and support of Commercial Holds for potential product escapes.Drive continuous improvement actions to reduce manufacturing defects.Provide leadership and subject matter expertise in QA activities to the overall site.Qualifications:BS in a science, engineering or related disciplineMS, CQE, or CRE preferred.Six Sigma Green or Black belt preferred.Minimum of 4 years’ experience preferred
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