Quality Engineer with QMS experience in the medical devices sector required by innovative medtech company in Dublin.
Reporting to the Director of Engineering and Regulatory Lead you will Establish the quality management system in line with ISO 13485: 2016 & FDA requirements & develop appropriate structures and interface mechanisms to control sub-contract manufacturing activities.
- Degree in Engineering or Science discipline or equivalent is essential.
- Minimum of 3-5 years experience in the medical device industry in quality or engineering
- Experience in dealing with regulatory auditors in context of Notified Body, FDA or MDSAP inspections
- Qualification in Auditing or Lead Auditor certification beneficial
- Experience using QA software tools and processes including Microsoft office
- Establish the quality management system in line with ISO 13485: 2016 & FDA requirements
- Manage the in quality and design assurance processes with key attention to technical file assembly and management
- Develop appropriate structures and interface mechanisms to control sub-contract manufacturing activities, with responsibility for oversight and control
- Ensuring appropriate evaluation of suppliers & sub-contract manufacturing activities with area focused on continuous improvement of products and processes
- Support the management review process and oversee change control activities for the site
- Work closely with R&D and Manufacturing to execute product and process verification and validation activities in accordance with quality system procedure and state of the art standards
- Manage the change control process between for the site and subcontract manufacturing ensuring that necessary quality agreements are established and maintained
- Support the risk management activities in compliance with ISO 14971 and manage associated device file assembly
- Develop appropriate product and component inspections and process monitoring criteria and methods to ensure compliance to business expectations is achieved
- Own and manage manufacturing internal and supplier driven non-conformances (NCs) and CAPAs, ensuring timely containment actions, corrections, root cause investigation, implementation of corrective actions and closure
- Monitor KPIs for monitoring of process and/or product quality, perform analysis and interpret trends
- Develop management review process to ensure regular assessment and reporting with key alerts and targets defined
Please send your CV in confidence to firstname.lastname@example.org