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.