Senior Quality Systems/Operations Engineer
Our client is an innovative and exciting Medical Devices organisation which has its R&D facility based in Galway. This organisation sets trends in research-intensive areas with their products and services designed to benefit people and improve their quality of life.
Our client is currently seeking a Senior Quality Systems Engineer/Operations Engineer to be a part of their fast paced team of seven to hit the ground running at their facility based in Galway. The role is contract based for 9 months and you will be reporting to the Quality Assurance Director, focused on ensuring Quality Assurance support is given and Product Quality and Regulatory needs are met.
The key responsibilities of your role as Senior Quality Systems/Operations Engineer will be:
- Managing the field complaints handling systyem, CAPA system and audit system ensuring all aspects are closed out in a thorough and timely manner. Manage the audit schedule and perform audits as required. Drive investigation into audit actions so that audit actions are closed out in a thorough and timely manner.
- Taking ownership for activities associated with supplier management. This includes supplier selection, approval, monitoring and reporting.
- Supporting the activities associated with preparing the QMS to achieve certification to FDA and PMDA regulations as well as the upcoming ISO and MDR requirements.
- Providing support to, and interacting with, the finished device Manufacturing Subcontractor to ensure that product quality requirements are achieved.
- Providing support to, and interacting with, suppliers to ensure that component and material quality requirements are achieved.
- Ensuring that Product manufacture and release activities are performed in a manner that is compatible with regulatory requirements.
The ideal Senior Quality Systems/Operations Engineer will:
- Be educated to a minimum Diploma level in an engineering, science or quality assurance discipline.
- Have upwards of 10 years of experience within a medical devices manufacturing environment.
- Have experience of CAPA’s, Auditing and Medical Device regulations (desirable), and management of CAPAs, Complaints, Audit Systems and Supplier Management (essential).
- Be innovative, flexible and able to hit the ground running in a fast paced environment.
- Competitive salary
- Health insurance
- Life assurance
To learn more apply online or contact Orla Boyle at HRM directly on +353 91 782110 for a confidential chat.
Salary: €50000 - €52000