Quality Engineer

Quality Engineer (Compliance) - 12 Month Contract Responsibilities: Manage Change Control Requests as a quality resourcePlanning, coordinating, executing, documenting and performing pFMEA, validation studies, process capability studies and process improvementsParticipate (by reviewing and evaluating impact) in the disposition of non-conforming material decision-making process.Co-ordinate the Ballina Ostomy QMS processes e.g. customer complaints system, CAPA system and internal audits.Develop Quality Plans and work instructions, documenting proceduresSupport strategic projects aligned with Plant QA, Global Supplier Quality, Plant Operations and Global EngineeringConduct defect awareness training sessionsParticipate in internal/external auditsEssential functions of the role: Knowledge and application of basic statisticsGood Communication skills, both written and oralStrong technical writing skillsAbility to train/facilitateKnowledge and implementation of medical device Quality System requirements (FDA and ISO) and Good Manufacturing Practice preferredKnowledge of Lean and Six Sigma principlesAbility to achieve results through working with cross functional teamsProficient computer skills, including Microsoft Office Suite (Word, PowerPoint, Project, Access, and Excel).Education/Work Experience Requirements: 2-4 years of experience in Quality Engineering or equivalent industry disciplinesExperience in medical device manufacturing regarding Quality System requirements per 21 CFR 820 and/or ISO 13485 preferredDegree in Engineering/Science Discipline or related study
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