Quality Engineer

4 weeks ago


Municipal District of Nenagh, Ireland TN Ireland Full time

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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