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Senior QA Engineer - QA Program Lead

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Date: Aug 3, 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 represent QA on the NPI program team.

Understand interdependences across NPI projects and Continence Care sites, through to distribution and drive appropriate action.

In addition support the delivery of Global Quality Strategy at the Ballina Continence Care site. 

 

RESPONSIBILTIES: 

 

QA oversight of NPI program through to Production & ramp up of production

Represent QA at NPI program meeting i.e. QA program update 4-square

Submit QA update on NPI for Global Quality Regulatory and Clinical monthly meeting

Understand interdependencies across projects & sites

Understand & compile a list of QA risks across each project/site

Work with risk owners on mitigation plan to understand action, timeline, impact to overall project

Co-ordinate (as required) cross site/program actions

Initial Point of contact for project Design Assurance/QA and Site Functional Managers for escalation of NPI related quality issues

Program Lead for delivery of Global Quality Strategy at the Ballina Continence Care site.

Other responsibilities:

Complete internal audits per the audit schedule

Complete CAPA investigations

Lead Hollister Production System (HPS) audits for the department

Other duties as required.

 

The suitable candidate should have a working knowledge of Design Controls, Design and Process Validation, Process Risk Management, be able to provide QE support for New Product Development (NPD) projects and change controls

They should also be proficient in working in cross functional teams, be able to coordinate cross functionally and cross site

Strong communication skills essential

 

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 working cross functionally

Master’s degree in Engineering/Science Discipline an advantage

Experience in Project/ Program Management 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: 30503


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