Quality Engineer

We Make Life More Rewarding and Dignified Location: Ballina
Department: Quality
Responsibilities: Participate (by reviewing and evaluating impact) in the disposition of non-conforming material decision-making process.Co-ordinate the Ballina Continence QMS processes e.g.
customer complaints system, CAPA system and internal audits.Develop Quality Plans and work instructions, documenting procedures.Support strategic projects aligned with Plant QA, Global Supplier Quality, Plant Operations and Global Engineering.Conduct defect awareness training sessions.Participate in internal/external audits.Essential functions of the role: Knowledge and application of basic statistics.Good communication skills, both written and oral.Strong technical writing skills.Ability to train/facilitate.Knowledge and implementation of medical device Quality System requirements (FDA and ISO) and Good Manufacturing Practice preferred.Knowledge of Lean and Six Sigma principles.Ability to achieve results through working with cross-functional teams.Proficient 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 disciplines.Experience in medical device manufacturing regarding Quality System requirements per 21 CFR 820 and/or ISO 13485 preferred.Degree in Engineering/Science Discipline or related study.About Hollister Incorporated


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