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Senior Quality Engineer

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Date: Apr 15, 2021

Location: Ballina, MO, IE

Company: Hollister Incorporated

Summary

The primary purpose of the Ostomy Senior QE role is to support Ostomy projects and support any other QA activities on site as required. The primary customers include Ballina Engineering, Manufacturing, Supply Chain Management and Product Development.

 

Responsibilities:

  • Complete Process and Equipment Validation including DV, FAT, IQ, OQ, PQ protocol development, implementation and report completion per timelines
  • Support Ostomy Compliance activities and support quality improvement projects
  • Completion of statistical analysis in compliance with Quality System requirements
  • Leading and executing PFMEAs.
  • Mentor and support Ostomy QEs through projects and ensure completion of projects per timelines
  • Lead Ostomy projects and ensure completion of projects per timelines
  • Work with the Validation Supervisor on team development activities
  •  

Requirements

  •  Number of Overall Years Necessary: 5-8
  •  Relevant experience in the medical device industry or equivalent regulated industry
  • Degree in Engineering/Science Discipline and Quality Engineering Qualification or equivalent

  • Knowledge of statistical analysis, ISO 13485 and FDA 21 CFR Regulations


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.

 

Hollister is an EO employer - M/F/Veteran/Disability

Job Req ID: 28826


Job Segment: Product Development, Supply, Supply Chain Manager, Quality Assurance, Supply Chain, Research, Operations, Technology