Quality Engineer

Date:  Jun 20, 2024

Ballina, MY, IE, F26 F3X5


Ballina, MY, IE, F26 F3X5

Company:  Hollister ULC

We Make Life More Rewarding and Dignified 

Location: Ballina 
Department: Quality 



Quality Engineer - 18 Month Contract



  • 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  disposition of non-conforming material decision-making process.
  • Investigate and resolve customer complaints and CAPAs, implementing solutions
  • Develop Quality Plans and work instructions, documenting procedures
  • Support strategic projects aligned with Plant Operations, Engineering and Global Engineering 
  • Conduct defect awareness training sessions
  • Participate in internal/external audits
  • Manage or support equipment calibration processes


Essential functions of the role:

  • Knowledge and application of basic statistics and experimental design
  • 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 
  • Proficient computer skills, including Microsoft Office Suite (Word, PowerPoint, Project, Access, and Excel).


Education/Work Experience Requirements:

  • Minimum of 2 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 the advancement of innovative products for ostomy care, continence care and critical care, and also creates educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, Hollister has manufacturing and distribution centers on three continents and sells in nearly 80 countries. Hollister is a wholly owned subsidiary of The Firm of John Dickinson Schneider, Inc., and is guided both by its Mission to make life more rewarding and dignified for people who use our products and services, as well as its Vision to grow and prosper as an independent, employee-owned company, and in the process, to become better human beings.

Hollister is an EO employer – M/F/Veteran/Disability
Job Req ID: 33076

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