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Quality Engineer, Validation

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Date: Jun 22, 2022

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 Quality Engineering and Process Validation services for Continence products in the Ballina Continence Care Plant and so contribute to the growth and profitability of Hollister. Projects will include supporting the qualification of new equipment and up-grades to existing equipment. 

RESPONSIBILTIES:

 

  • Complete Process and Equipment Validation including FAT, SAT, IQ, OQ, PQ protocol development, implementation and report completion.
  • Conduct Risk Management / FMEA / Statistical analysis.
  • Conduct process capability assessment as part of process changes management.
  • Implement process control and ensure process capability is maintained and identify opportunities for process improvement.
  • Conduct CAPA analysis to determine root cause and complete problem resolution.
  • Ensure process changes are implemented per change control procedures.

 

QUALIFICATIONS: 

 

  • Degree in Engineering/Science Discipline
  • Quality Engineering Qualification
  • 3-5 years’ experience in Medical Device Industry utilising high volume automated equipment
  • Experience in Quality Validation.
  • Ability to participate in cross functional teams

 

Hollister Incorporated is an independent, employee-owned company that develops,manufactures, and markets healthcare products worldwide. The company develops and manufactures products for ostomy care, continence care and critical care, and also develops educational support materials for patients and healthcare professionals. Headquartered in Libertyville, Illinois, it 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 (JDS Inc), a 100 year old company. Hollister is guided by the shared Mission of JDS Inc, to make life more rewarding and dignified for people who use its products and services.  www.Hollister.com 

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


Job Req ID: 30481


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