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Design Assurance Quality Engineer

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Date: Jan 13, 2021

Location: Ballina, MO, IE

Company: Hollister Incorporated

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 Ballina Continence Care Design Control CCs. This is a 12 month fixed term contract. 

RESPONSIBILTIES:

  • Act as a team member on Design Control CCs representing Quality Management
  • Part of a cross functional team to complete an assessment on Product Design and Process information
  • Facilitate Design Controls, Risk Assessments and DFMEA
  • Supports planning of Design Verification & Validation activities
  • Supports pFMEA, Process Validation and related training of associates
  • Support remediation of Design History Files
  • Support CAPA analysis and problem solving

 

QUALIFICATIONS: 

  • Degree in Engineering/Science Discipline
  • Quality Engineering Qualification / ASQ CQE certification
  • Experience of Design Controls / New Product Commercialization projects
  • Experience of Design History Files in a Medical Device Environment
  • Experience in statistical analysis / process validation
  • 3-5 years’ experience in Medical Device Industry
  • Strong communication skills

Hollister Incorporated is an independent, employee-owned company that develops, manufactures, and markets products for ostomy care, continence care, and wound care and develops educational support for patients and healthcare professionals. We have been in business for more than 95 years. Our products are sold in more than 90 countries and we have manufacturing and distribution centers on three continents. At Hollister Incorporated, we are passionate about the work we do, and we are committed to making life more rewarding and dignified for our Associates and for the people who use our products and services. A career at Hollister Incorporated can take many paths, all of them leading to rewarding opportunities.


Job Req ID: 28547