Quality Systems Engineer

Ref. no.: 105050

Tags: Quality Systems Engineer

Location(s): Galway Roscommon Westmeath

Salary range (€): Negotiable

Additional benefits:

Minimum experience required: 2 - 3 Years

Employment type: Permanent Full-time

Minimum qualification: Third Level Degree

Contact person: Melissa Foley

Contact e-mail: mfoley@brunel.ie

Job description:  

Quality Systems Engineer (QSE)

Major Duties and Primary Responsibilities:

Document Control
· Manage all controlled documentation in all its media variants
· Create and maintain Controlled Document Stations (CDS) as appropriate.
· Create user accounts and provide rights / roles accordingly for personnel, as appropriate.

Change Control System
· Manage change control system through Smart.solve
· Train personnel on change order process
· Assist personnel with creating and/or processing change orders
· Tracking and management generated change orders
· Generate management metrics on change order system

C.A.P.A Systems
· Manage C.A.P.A. system through Smart.solve
· Train personnel on C.A.P.A. process
· DHR review of Field complaints relating to manufacturing

• Manage complaint files
• Tracing and pulling relevant DHRs
• Organise weekly complaints meeting
• DHR reviews for complaint files
• Responding to relevant KCI department of DHR reviews

Systems
· Create and maintain internal auditing schedule
· Complete internal audits as required

Requirements:

• Bachelor's degree in Engineering, Science or related subject.
• A minimum of 3 years industry experience. Medical device experience strongly preferred.
• Experience in working in High Volume Production Facility
• Familiarity with ISO quality systems (ISO9001, ISO14001 and/or ISO13485)

Please forward your CV to mfoley@brunel.ie or

for further information contact Melissa on 061-430950