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
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.

EOE Statement
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Job Req ID: 33991