Quality Systems Engineer
Permanent
Leitrim
Leitrim
Role
Quality Systems Engineer
Role Overview
Required Qualifications/Experience/Skills:
Required:
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