Quality Engineer

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This project has been archived and is not accepting more applications.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

Description

I have an immediate opening for a Quality Engineer - Manufacturing Support with a fantastic medical device company based in Limerick. This is a 12 month fixed term contract position.

The Quality Engineer- Manufacturing support will be the primary contact between Quality Assurance and Manufacturing. This person will provide expert QA support to Operations, in ensuring goals and objectives are achieved for the plant.

Responsibilities:
Provide effective and responsive QA support to Operations to resolve in-house, customer and supplier issues.
* Ensure Regulatory compliance in area of responsibility to GMP of all medical devices regulatory agencies (i.e. FDA, IMB and BSI).
* Assist in development, review and approval of process and equipment validation (IQ, OQ and PQ).
* Ensure compliance of QMS procedures within the Business Unit.
* Lead Problem Solving meetings using the following: 4D, Six Sigma, etc.
* Lead pFMEA/Dynamic Control Plan (DCP) activity and ensure that all failure modes in process have been identified and addressed.
* Drive and implement plant wide quality system improvements.
* Participate in the development and improvement of the manufacturing processes for existing and new products. Coordination of PPAP activities.
* Provide functional expertise to other support function on quality related issues.
* Manage NCR Process.
* Interface with Suppliers for new processes, quality Issues and Process Improvements.
* Work cross functionally with such groups as Regulatory, Product Development and Operations to ensure all issues are successfully resolved.
* Lead training activities on Quality related Procedures, e.g. Compliance, GMP, Audit Prep and GDP.
* Support Manufacturing Cell in addressing Quality Metrics, e.g. CAPA, sCAPA, Validations, Process Changes, NCR, Quality Alert, Quality Challenge.
* Complete Manufacturing Cell Audits, Internal Audits Supplier Audits, as required.
* Support site during External Audits. (i.e. FDA, IMB and BSI).
* Support/ act as local subject expert for review, creation and training of divisional/corporate procedures.
* Responsible for input to Quality Metrics.
* Evaluation of Customer Complaints (PER Investigation) as required.

Qualifications
Degree in Engineering, Science or equivalent is required.
* Minimum of 2 years experience in a QA role.
* Good level of technical and analytical skills.
* Problem Solving Skills and ability to handle multiple tasks in a fast paced environment.
* Capable of working as part of a multi discipline team.
* The individual should enjoy working in an aggressive, dynamic and results motivated team environment.
* High level of PC skills required.
* Excellent Communicator

If you are interested in this position please apply directly to this advert or contact Derek Sheridan on for immediate consideration.
Start date
06/2015
From
Real Staffing
Published at
15.05.2015
Project ID:
905426
Contract type
Permanent
To apply to this project you must log in.
Register