Quality Engineer

Dublin  ‐ Onsite
This project has been archived and is not accepting more applications.
Browse open projects on our job board.

Description

I have an immediate job opening for a Quality Engineer with a leading medical device company based in Dublin. This is a fantastic opportunity to join a rapidly growing company on a permanent basis.

You will be responsible for liaising with company wide departments to ensure internal system compliance and customer specifications are achieved. Ensure the timely and effective closure of internal/external quality issues. Coach and drive a culture of compliance and continuous improvement.

Requirements:
  • Must have a third level qualification in Engineering/Quality/Science.
  • Must have 2+ years work experience in a Medical Device manufacturing environment.
  • A working knowledge of quality systems such as ISO CFR Part 820 is essential.
  • Must have a working knowledge of statistics, SPC, and ideally the use of Minitab.
  • Must have an in-depth knowledge of validations in a Medical Device environment.
  • Must have excellent communication skills both oral and written.
  • Auditing experience to the requirements of ISO CFR Part 820 is preferred.


Responsibilities:
  • Interface on an ongoing basis with customers to ensure requirements / concerns/complaints are communicated and corrective actions are closed in a timely and effective manner.
  • Management of customer documents into the Quality system ie Drawings; Purchase Specification; Quality Agreements etc. and the training out of relevant personnel.
  • Drafting and approving of quality documentation to meet company and Customer requirements ie Quality Specification Sheets (QSS), CAPA's, Defect Library etc.
  • Participate in the review of validation protocols and reports to ensure quality compliance.
  • Review of quality document to drive compliance ie batch reports, metrology reports etc.
  • Executing internal process and system audits.
  • Manage quality projects in support of continuous improvement eg. Lean Projects.
  • Co-ordinate activities associated with change management and customer interaction.
  • Ensuring the timely and effective closure of day-to-day quality issues.
  • Interface with other departments on a daily basis.
  • Batch paperwork review and final decision to release product for shipment
  • Analysing and reporting of key measures eg. Ppk's, Cpk's, Cost of Quality, Customer Complaints, and Internal/external quality results.


If you are interested in these excellent opportunities please apply directly to this advert or contact Derek Sheridan on for immediate consideration.
Start date
09/2015
From
Real Staffing
Published at
07.11.2015
Project ID:
1015109
Contract type
Permanent
To apply to this project you must log in.
Register