Senior Design Assurance Quality Engineer I
Ballina, MY, IE, F26 F3X5
Ballina, MY, IE, F26 F3X5
We Make Life More Rewarding and Dignified
Location: Ballina
Department: Quality
Summary:
The purpose of the position is to provide Design Control Quality Engineering services for Continence products in the Ballina CCBM Plant and so contribute to the growth and profitability of Hollister.
Responsibilities:
- Act as a core team member on Continence NPC projects representing Quality
- Facilitate Design controls, Risk Assessments, DFMEA
- Support specification and drawing development, PFMEA and Process Validation for NPC projects
- Complete ISO 13485 / FDA and QSR internal audits per annual schedule.
- Support CAPA analysis and problem solving as required for NPC projects and processes
- Statistical Analysis
- Personnel training.
Work Experience
• 5-8 years’ experience in Medical Device Industry
Education Requirements
• Degree in Engineering/Science Discipline
• Quality Engineering Qualification / ASQ CQE certification
• Experience of Design controls / NPI projects
• Experience in statistical analysis / process validation
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: 35395