Senior Quality Engineer
Due to continued business growth, we are currently recruiting for Senior Quality Engineer based in Limerick. This position will be offered on a permanent contract working full time.
Reporting to the Quality Manager
Duties:
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products
• Champion compliance to applicable Global Regulations and standards (eg. US FDA, 21 CFR 820, ISO and IVDR: In Vitro Diagnostics Regulation)
• Identify quality systems engineering improvement opportunities and executes through the change management system
• Perform test method validations and component qualifications as required
• Develop complex experiments and tests (including writing and executing protocols) to create, validate, and improve products (including evaluation of source materials and suppliers) and manufacturing processes/methods based on engineering principles; analyze results, make recommendations, and develop reports
• Collaborate with Quality Manager to ensure quality management system is maintained and continually improving
• Responsible for the Manufacturing Quality support function including approvals in the change control process and ongoing compliance, in conjunction with the appropriate resources.
• Generation of reports for data trending and analysis of the process (as required).
• Serve as a resource to NC/CAPA investigations for conducting root cause analysis and developing and implementing corrective action plans.
• Drive investigations, perform robust root cause analysis, develop and implement corrective actions, and establish effectiveness monitoring plans
• Maintain a proactive approach to developing the Quality system to meet the changing needs of the business.
• Ensure that all Quality issues are effectively arranged and acted upon in a timely manner.
• Ensure compliance for manufactured and distributed products
• Represent quality department in company projects where required
Essential Criteria:
• A minimum of a Bachelor’s degree (Hons) in Engineering, Technology, or Science. (Level 8).
• Previous experience (ideally minimum 5 years) of working with ISO13485, ISO14971, the IVD / IVDR: In Vitro Diagnostics Regulation and the FDA QSR including 21 CFR Part 820 and 21 CFR Part 11.
• Qualified Lead Auditor in ISO
• Excellent working knowledge of 21 CFR 820 and ISO 13485 standards
• Knowledge of CE IVD regulations
Contact niamh.hoare@eflexes.com or 0858734617
