Quality Systems Engineer

Permanent
​​Leitrim
Role                                                                                            
Quality Systems Engineer
 
Role Overview 
  • Assisting the Quality Management Function with the:
    • Co-ordination, Maintenance & Integration of the Quality Management System with all processes in accordance with the requirements of ISO 13485, FDA QSR 21 CFR Part 820, & MDD 93/42/EEC. (MDR 2017/745/EU).
    • Establishing, Implementation and Maintenance of the processes necessary for the Quality Management System e.g., CAPA system
    • Assist in the generation of reports to be presented to management on the performance of the Quality Management System.
    • Participate in Management Review Meetings and assist in the compilation of the management Review presentation slides and Minutes.
    • Assist in the co-ordination & maintenance of the Customer Complaint investigation process, vigilance reporting requirements, MDR requirements, and product recalls where necessary.
    • Assist with the co-ordination & maintenance of the Plant Corrective & Preventive action programme.
    • Participation & Maintenance of plant Continuous process improvement programmes.
    • Participate in Root Cause Analysis process when required.
    • Execution of Internal Quality and Environmental Audit programme, and participation in the Vendor Management process.
    • Maintenance, Review & Approval of Quality System Manual & Policies.
    • Controlling the implementation and release of Procedures & documents that are impacting on the Quality Management System (QMS), Environmental Management System (EMS), Health & Safety and Energy.
    • Provide ‘In-House’ Training on Quality System Updates or to raise awareness of regulatory & customer requirements when required.
    • Perform system & Document updates to the QMS and EMS arising from changes to the Corporate procedures.
    • Raising corporate Change Orders when required.
    • Lead &/or participate in relevant Projects that impact the QMS or EMS as they arise within the Company.
    • Participation in the Risk Management programme when required.
    • Review & Approval of Customer Finished goods Labels when required.
    • Adhere to Plant Safety requirements and Health & Safety requirements relating to your work, assuming responsibility for those aspects of the OH&S System over which you have control to ensure the health and safety of yourself and others.
    • Be aware of the potential environmental impacts associated with your work and the implications of non-conformance.
    • Contribute to enhanced energy performance by conservation of energy where possible (Lighting, Equipment, Air Conditioning etc).
    • Contribute to the continual improvement activities of the OH&S, Environmental and Energy Management systems through participation, providing feedback/ suggestions for improvement and by reporting accidents, dangerous occurrence, near miss/ illness, good catch and environmental incidents in a timely manner.
 
 
 
Required Qualifications/Experience/Skills:

 
Required:
  • Minimum of 5 years experience in Quality System Administration in the Medical Device Industry, preferably for ISO 13485 &/or FDA QSR 21 CFR Part 820.
  • Good knowledge of ISO 13485, FDA QSR 21 CFR Part 820 regulatory standards, and the Medical Device Directive 93/42 EEC.
  • Good Knowledge and understanding of cGMP and GDP.
  • Qualified Lead Auditor.
  • Experience in conducting Vendor Audits and reporting on same.
  • Experience in managing/participating in Internal & External Audits (customer and/or Regulatory body audits).
  • Experience in completing Change management processes (Change Control).
  • Experience in managing &/or participating in a variety of Quality System processes, CAPA, NCMR, Deviations, SCARS etc