We Make Life More Rewarding and DignifiedLocation: BallinaDepartment: QualitySummaryThe 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.ResponsibilitiesAct as a core team member on Continence NPC projects representing QualityFacilitate Design controls, Risk Assessments, DFMEASupport specification and drawing development, PFMEA and Process Validation for NPC projectsComplete ISO 13485 / FDA and QSR internal audits per annual schedule.Support CAPA analysis and problem solving as required for NPC projects and processesStatistical AnalysisPersonnel training.Work Experience5-8 years' experience in Medical Device IndustryEducation RequirementsDegree in Engineering/Science DisciplineQuality Engineering Qualification / ASQ CQE certificationExperience of Design controls / NPI projectsExperience in statistical analysis / process validationAbout Hollister IncorporatedHollister 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 StatementAll 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