Quality Assurance Engineer

Hrm

Roscommon

Our client a global medical device organisation based in Roscommon offer state of the art medical device components and products to their wide range of customers and patients, providing solutions to patients with debilitating diseases and improving quality of life. The Role: Reporting to the Quality Assurance Manager, you the QA Engineer will provide ongoing support to the manufacturing team to maximise production quality performance, including identifying root cause, implementing corrective/preventive action on all quality issues. Scope of role will also include addressing any customer related issues identified in the manufacturing process and validation of new processes/products. The Responsibilities. Review, update and maintain existing quality management processes and procedures. Initiate and drive Continuous Improvement programs, Host audits of the Company's operations by external bodies (e.g. audits from customers, audits relating to certification to official standard e.g. ISO 9001, ISO 13458. Maintain detailed and accurate quality records, data analysis and documentation, Non-conforming Material, Customer Complaints, CAPA investigation, analysis and improvement, Data Analysis and Trending, Statistical Process control, Root Cause Analysis and the Implementation of Corrective Actions. Prepare and execute Process/Product Validations, Ensure new product introductions and change controls are effectively managed in accordance with the ISO requirements when appropriate, Supporting the introduction of new product lines through development of Product Inspection Plans, Process FMEAs and Risk Management Plans. The Person: A Degree in Science/Quality Assurance or equivalent. Minimum of 5 years' experience in a Quality Engineering role, preferable in the Healthcare/Medical Device Sector. To learn more apply online or contact Orla Boyle at HRM directly on 353 91 782110 for a confidential chat. This job originally appeared on RecruitIreland.com.

2192 days ago