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Associate Quality Engineer

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Date: Jun 5, 2022

Location: Ballina, MO, IE

Company: Hollister Incorporated

HOLLISTER INCORPORATED

POSITION DESCRIPTION

 

 

I.         IDENTIFICATION:

Title                                        Associate Quality Engineer                     

Position Number                     IIIA                

Hierarchal Level                     Exempt Staff  

Division/Department              Quality Assurance Ostomy                                              

Reporting Relationship           Validation Supervisor

Travel                                      Limited

Staff reporting to position      N/A

Operational budget                 N/A                            

Sales Target/Financial Goals  N/A

 

 

II.        AUTHORIZATIONS: 

Department Manager                                      Quality Assurance Manager

 

Functional VP                                                 VP Quality Assurance

 

 

III.      SUMMARY: 

The purpose of the position is to support Quality Engineering and Process Validation services

For Hollister Ballina.

 

  1. RESPONSIBILTIES:
  • Support and execute cost of quality and project improvement initiates.
  • Conduct, lead or direct investigation and product risk assessments in relation to product/quality complaints
  • Product/Quality complaint metric reporting and trending
  • Support ISO 13485 / FDA and QSR internal audits per annual schedule.
  • Support the implementation of 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.
  • Support Process and Equipment Validation including DV, IQ, OQ, PQ protocol development, implementation and report completion.
  • Support the development product specifications / drawings / quality plans in conjunction with NPD and project team.
  • Conduct Risk Management / FMEA / Statistical analysis.
  • Personnel training.

 

 

 

 

 

 

VI.       QUALIFICATIONS: 

 

Required qualifications:

  • Degree in Engineering/Science Discipline (or undertaking qualification)
  • 2/3 years’ experience in Medical Device Industry
  • Ability to participate in cross functional teams

Desired qualifications:

  • Quality Engineering Qualification (or undertaking qualification)
  • Experience in statistical analysis / process validation

 

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: 29923


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