Associate Quality Engineer
Our client, a medical device company in Galway are currently looking to recruit an Associate Quality Engineer for their site.
Key responsibilities may include the following:
- Support of subcontractor and vendor system activities including completion of initial assessments, professional maintenance of files and periodic review and ongoing assessment.
- Supporting & executing processes which ensure personnel involved in the manufacture of the company product including subcontractor staff have appropriate training in quality, procedures and completion of paperwork prior to working on the production of the company's product.
- Monitoring the company production, wherever it is performed, in compliance with appropriate, approved and current contracts and procedures.
- Supporting activities related to the planning and implementation of product and manufacturing process change.
- Supporting the timely review and approval of production records and sterilization records prior to release of each batch of product.
- Supporting the company's oversight of routine monitoring and management of the product bioburden, including feedback to quality management on deviations or issues of concern.
- Activities related to the company systems for CAPA, non-conformances and for supplier corrective actions.
- Activities related to the management of the company's Calibration system.
- Preparation of data on production, environmental monitoring, vendor assessment, non-conformances and supplier corrective actions for use in management review.
- Supporting internal/supplier audits as scheduled and maintaining audit records.
- Support bench test activity as required.
- Support regulatory activities as requested by management.
- Represent the company professionally and positively externally to agencies, sub-contractors, vendors and regulators.
- Quality Director/ Quality Systems Manager
- Project Manager, Operations
- Employees and contractors working in the areas of quality, regulatory and manufacturing
- Minimum education of degree in a technical field.
- Ability to communicate clearly, accurately, and directly, both verbally and in writing, to a widely varied audience the regulatory or quality function.
- Accuracy of information essential
- Ability to work well under deadlines and pressure
- Balanced and Dependable
- Approachable and enthusiastic
- Flexible and adaptable.
- Able to work on own initiative and as a team player.
- Excellent accuracy
- Clear communicator
- Good judgment and problem solving ability & is capable of understanding the impact of decision making on both the company and end users.
- Able to build good, strong and positive working relationships with cross functional teams internationally.
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