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
Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets healthcare products worldwide. The company spearheads
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