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Senior Quality Engineer

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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 

HOLLISTER INCORPORATED

POSITION DESCRIPTION

 

 

I. IDENTIFICATION:

 

Title       Senior Quality Engineer  

Hierarchal Level     Exempt Staff 

Division/Department    Quality Assurance     

Reporting Relationship    Validation Project Manager, Continence Care

Travel      Limited

Staff reporting to position    N/A

 

 

II. SUMMARY:  

The purpose of the position is to provide Quality Engineering services for the Ballina

Plant Value Stream (Continence Care) and so contribute to the growth and profitability of Hollister.

Develop and implement Master Validation Plans, Risk Assessments and lead QE activities in the Value Stream. 

 

 

III,  RESPONSIBILTIES: 

Develop Master Validation Plans 

Develop and complete DV/IQ/OQ/PQ protocols

Contribute to the development of FAT/SAT protocols

Execute Validation Protocols, root cause deviations and generate validation reports

Develop product specifications / drawings / quality plans in conjunction with NPD personnel

Provide QE support for New Product Development (NPD) projects

Process Risk Management / FMEA

Complete internal audits per the audit schedule

Co-ordinate and implement process capability analysis on catheter processes

Complete CAPA investigations

Lead Hollister Production System (HPS) audits for the department

Supervision of Quality Engineers and Associate Quality Engineers during project activities

 

 

IV. QUALIFICATIONS:  

(Bona-fide minimal qualifications for the position)

Degree in Engineering/Science Discipline and Quality Engineering Qualification

Experience in statistical analysis / SPC / validation of automated equipment

8 years’ experience in Medical Device Industry utilizing automated equipment

Experience of people management

Master’s degree in Engineering/Science Discipline an advantage

 

 

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: 30480


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