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Quality Engineer, Compliance

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Date: Aug 14, 2019

Location: Ballina, MO, IE

Company: Hollister Incorporated

We Make Life More Rewarding and Dignified

Location: Ballina Office 
Department: Quality 

SUMMARY:

The purpose of the position is to provide Quality Engineering services for Continence products in the Ballina CCBM Plant. This is a 12 month contract.

 

RESPONSIBILTIES:

  • Support Process and Equipment Validation including IQ, OQ, PQ protocol development, implementation and report completion as required.
  • Conduct Risk Management / FMEA / Statistical analysis.
  • Complete ISO 13485 / FDA and QSR internal audits per annual schedule.
  • Support complaint trending / resolution as required.
  • Conduct CAPA analysis to determine root cause and complete problem resolution.

 

QUALIFICATIONS:

 

  • Degree in Engineering/Science Discipline
  • Experience in Quality function in the medical device industry
  • 2/3 years experience in Medical Device Industry
  • Ability to participate in cross functional teams

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

Job Req ID: 27511


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