Senior Quality Systems Engineer

Galway  ‐ Onsite
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Keywords

Description

I have an immediate opening for a Senior Quality Systems Engineer with a fantastic medical device company based in Galway on a permanent basis.

The Senior Quality Systems Engineer will co-ordinate all activities relating to the operation of and improvement of the ISO 13485:2003 Quality Management System. This person will be responsible for ensuring on-going compliance to Quality Systems Requirements in all activities in the operation.

Duties and Responsibilities
* Ensure compliance across all aspects of the operation to the requirements of ISO 13485:2003 Quality Management System.
* Responsible for Complaint Management. Works with Cross Functional Teams in co-ordinating investigations, determining root cause, implementing Corrective and Preventive Actions arising from the investigation. Generates Customer Reports arising from these investigations.
* Management of Internal Audit Process. Generates Internal Audit Schedule, co-ordinates audits and associated Corrective/Preventive Actions. Ensures audits are carried out and followed up in timely manner.
* Preparation/Management of Customer Audits and External Body Audits.
* Management of Corrective / Preventive Action System. Responsible for reviewing status, content and timelines of Corrective /Preventive Actions.
* Direct responsibility for managing Document Control System.
* Generation of Quality System Metrics e.g. Complaints, CAPAS, Audits etc.
* Generation of Management Review Presentations.
* Ensuring Risk Management and Validation Strategy are current and best practice.
* Communicates updates to Quality System Requirements.

Requirements
* Degree in Engineering/BSc/Quality Systems is essential.
* Min 5-10 Years' experience in Quality Systems Management in the Medical Device /Component Industry.
* Ability to lead and give direction to team members on all aspects of Quality Systems.
* Excellent Written and Verbal Communications.
* Excellent Administrative and Analytical Skills.
* Excellent Attention to Detail.
* A positive attitude in dealing with people.
* Ability to learn and adapt to varying demands and situations.

If you are interested in this role and feel you would be a good fit please apply directly to this advert or contact Derek Sheridan on for further information.
Start date
12/2014
From
Real Staffing
Published at
22.11.2014
Project ID:
812280
Contract type
Permanent
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