Quality Engineer - 6 Month Contract Location: Galway, Mayo, Clare Salary: 45 - 50k


 

Quality Engineer - 6 Month Contract

Ths organisation is a world leader in the manufacturing of medical devices and components and is an ISO 13485 and ISO 9001 registered company. Due to ongoing company expansion, they are currently hiring a quality engineer. The successful candidate will work as part of a team to maintain high quality / performance standards on all comnpany products. This position will be challenging and will require an ability to work with minimum supervision.

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.
• 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:
• Performing internal and external audits to ISO and FDA requirements.
• Upgrading system elements as appropriate.

Key Requirements:

• 5+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 this position please apply online or contact Kevin Carroll on 01 6321887.
YOUR CV WILL BE TREATED WITH THE STRICTEST CONFIDENCE
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