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Quality Engineer

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Date: Jun 2, 2019

Location: Ballina, MO, IE

Company: Hollister Incorporated

We Make Life More Rewarding and Dignified

Location: Ballina Office 
Department: Quality 

 

 

Global Position Description

Title:

Quality Engineer for Ostomy         

Hierarchical Level:

Professional

Division/Department:

Ballina/Ostomy QA Department

Reports to:

Senior Quality Engineer, Ostomy

Number of

Direct Reports:

0

Travel:

Possible

Revision Date:

4/5/2019

 

Job Level:

  HR To Determine

FLSA (US Only):

HR To Determine

Type of Position:

Salary

 

Summary:

The primary purpose of the Ostomy 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 timeline
  • Support Ostomy compliance activities and quality improvements, as required. 
  • Completion of statistical analysis in compliance with Quality System requirements
  • Leading and executing PFMEAs.
  • Assist in CAPA investigation.

 

Essential Functions of the Role**:

  • Walking
  • Lifting
  • Sitting

 

Work Experience Requirements

Number of Overall Years Necessary: 5-8

Relevant experience in the medical device industry or equivalent regulated industry

 

Education Requirements

Degree in Engineering/Science Discipline and Quality Engineering Qualification or equivalent

 

Specialized Skills/Technical Knowledge:

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

Local Specifications (English and Local Language):

English

 

** To comply with regulations by the American with Disabilities Act (ADA), the principal duties in job descriptions must be essential to the job. To identify essential functions, focus on the purpose and the result of the duties rather than the manner in which they are performed. The following definition applies: a job function is essential if removal of that function would fundamentally change the job.

 

 

 

Date Posted:

4/5/2019

 

Job Req ID: 27398


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