My client a world leading company in medical device is seeking a Quality Assurance Specialist for their east Galway site Reporting to the Global Quality Systems Manager, this position will have responsibility for assisting with design / support testing for company products, data analysis and reporting of Global Business Units performance and support functions of Global Quality Management System.
• Assist in establishing a proven method via test method validation with company technology via related procedures.
• Perform analysis of patch/solution samples using the FTIR machine. Summarize the findings in a report format at various indicated stages.
• Assist in the establishment of an efficacy test on products.
• Assist in establishing the shelf life of the products, while executing protocol and report documentation.
• Perform scheduled calibration of FTIR machine.
• Assist in the documentation of the method of action of the products.
• Assist in the investigation and establishment of any required test methods test to prove product efficacy / integrity.
• Perform literature reviews as required.
• Review of individual Business Unit monthly reporting and highlighting of any positive / negative trending.
• Collation of all Business Unit monthly metrics for Executive Team review.
• Assist/advise departmental / Business Unit Managers/Directors of QMS requirements as required.
• Document control activities with regard to Global Document Change Order requests and related processing, including filing and archiving Quality documents.
• Assisting with the generation / review of new and existing documentation via process review and brainstorming activities.
• Co-ordination of documentation distribution with Business Unit Managers and Management of related quality records.
• Maintenance of Global Training matrix.
• Assist in the investigation of customer complaints.
• Assist when requested in the preparation of documentation support of existing and new product lines.
• Assist in data analysis as required for the support of the Global Quality Management System.
• Support all audit activities related to notified bodies and local regulatory authorities.
• Support quality audits for vendors which have a global impact for company.
• Assist in the promotion of companywide quality improvement efforts.
• Additional duties as required.
• Third level qualification in related area essential.
• In depth knowledge of ISO 13485 and related requirements.
• Ability to use own initiative.
• Approximately 3-5 years’ experience in GMP, encompassing Quality Management Systems.
• Excellent IT skills , good technical capabilities, communication skills (both written and verbal) , teamwork abilities and initiative.
• High attention to detail.
• Good report writing skills.
For an immediate interview please forward your CV using the apply button
Or call Megan Warr on 091507515 for a confidential conversation