Quality Engineer

Galway  ‐ Onsite
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Keywords

Description

Our client, a leading contract manufacturer based in Galway, have an opening for a Quality Engineer. (Salary €45,000 - €50,000). This is a great opportunity to join a great company who provide excellent training and opportunities for career progression.

Job Responsibilities:

The quality engineer will perform an active role in quality planning and new product introduction, from a quality perspective. This will involve:

* Have a good working knowledge of ISO/EN/FDA/MDD and other Product Development related regulatory requirements
* Maintain relevant documentation to comply with quality standards and regulatory submissions.
* Develop strong links with customer organisations and other project stakeholders.
* Maintaining DFMEA's and customer design documentation.
* Mentor Quality Technicians in their role on production lines
* Be responsible for all Receiving and in process inspections for the product including sterilisation release.
* Provide input to root cause investigations and ownership for CAPA reports.
* Will have input and involvement in preparing customer project proposals
* Management New process validations and coordination of validation activates to meet project completion deadlines.
* Overall responsibility for production GMP standards and compliance
* Establishing inspection standards, plans, frequencies and test methods.
* Performing an active role in further development of the quality management system. This will involve:
o Performing internal and external audits to ISO and FDA requirements.
o Upgrading system elements as appropriate.

Key Requirements:
* 4+yrs industry experience in a medical device-manufacturing environment.
* Working knowledge of FDA and ISO Quality systems for Medical device companies.
* New product Introduction and manufacturing process transfer experience would be a distinct advantage
* Process validation experience including new process start-up, typically drafting MVP's, validation protocols and coordinating validation execution and FMEA activities
* Technical expertise in the review of technical files and design dossiers to ensure compliance to current standards
* Degree in Science or Engineering.

If you are interested in hearing more about this fantastic opportunity please respond with an updated CV or call me on for further information.
Start date
02/2015
From
Real Staffing
Published at
17.01.2015
Project ID:
836222
Contract type
Permanent
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