Job title: Quality Technician
Location: Ballybrit, Galway
Benefits: Salary, bonus, pension, healthcare and 4 day week


Job overview:
As a Quality Technician you will be responsible for the effectiveness of assigned areas of the company’s quality system. Provide support to the operations function and incoming. Maintain records in accordance with the quality system requirements, which show that products manufactured meet the requirements of end users, customers, regulatory authorities and the company. Maintain assigned areas of the quality system in accordance with the requirements of ISO13485, The Medical Device Directive 93/42EEC and FDA Quality System Regulations (if applicable).

The working week is a 4-day week from Monday- Thursday 7am -5.15pm on-site in a cleanroom and controlled manufacturing environment. This is initially a full time fixed term contract.



Responsibilities:

• Provides support to Manufacturing and Product Engineering and Quality Engineers for commercial/validation projects.
• Supports implementation and maintenance of manufacturing methods, processes and operations for new and existing products.
• Supports dispositions of nonconforming material and processes.
• Supports sustaining Engineering and QE in resolving Manufacturing issues in the plant.
• Participate in lean and cost reduction activities.
• Supports the conduct of investigations and associated actions related to CAPA and Internal/external audit activities.

• Review batch records and approve release of product. Provide accurate Certificates of Conformance and/or Certificates of Analysis.
• Effectively communicate with other staff, customers and suppliers in order to promote quality awareness and to conform to customer requirements.
• Identify areas for improvement and lead improvement initiatives.

• It is desirable that the Quality Technician should have a good level of education with strong experience in a Medical Device industry and working within Controlled Environments.
• Experience in medical device is essential, two (2) to five (5) years.
• Good interpersonal skills and have the ability to multi-task.
• Must be motivated and demonstrate the ability to be a self-starter