Dedicated to stoma care
Location: Ballina
Department: Quality
Quality Engineer (Compliance) - 12 Month Contract
Responsibilities:
* Manage Change Control Requests as a quality resource
* Planning, coordinating, executing, documenting and performing pFMEA, validation studies, process capability studies and process improvements
* Participate (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 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
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