Quality Systems Engineer
Hrm
Roscommon
Our client, a global healthcare organisation with 50 years of medical device experience, have developed a thorough understanding of the complex solutions to patients needs. They operate at a global level being experts in their area and providing high level products to their customers. The Role: Our client is currently seeking a Quality Engineer (Systems) to join their onsite Quality team and be a key team member in implementing the QMS onsite and the project management of this process whilst also supporting the manufacturing function. Key Responsibilities: Maintain quality system in accordance with the requirements of ISO13485. Review batch records and approve the release of product. Release finished product, monitor product sterility and sterilisation records as appropriate. Liaise with customers on all product-related queries, co-ordinate Customer-Request group, drive preventive actions and improve customer confidence. Manage the QA document control function, overseeing change control, SOP review, document storage/archiving. A key responsibility of this role will be co-ordinating the introduction of soft-format documentation via VQMS documentation system. Co-ordinate the CAPA system, convening the CAPA Review Board, driving corrective and preventive actions, assigning responsibilities and reporting trends. Lead/support Projects as required. Complete internal and vendor/contractor audits. Oversee the gowning and cleaning regimes in place, working with contractors to improve performance and maintain a clean environment. The Person. Degree qualified in quality management, engineering or science with minimum 5 years medical device/pharmaceutical and/or diagnostics manufacturing experience. 1 year experience in a quality department is desirable. Must have a good working knowledge of ISO13485, FDA Quality System Regulations. Ability to lead and conduct audits, and implement QMS. 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.
2234 days ago