Our client has a permanent Quality Systems Assistant job available in Leitrim
- 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.
- Establishing, Implementation and Maintenance of the processes necessary for the Quality Management System
- Assist in the generation of reports to be presented to management on the performance of the Quality Management System
- Promotion of awareness of regulatory and customer requirements, through GMP and other training,
- Assist in the co-ordination & maintenance of the Customer Complaint investigation process, MDD 93/42/EEC vigilance requirements, MDR, 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.
- Execution of Internal Quality and Environmental Audit programme, and participation in the Vendor Management process.
- Maintenance, Review & Approval of Quality System Manual, Policies & Procedures.
Education, experience and skills:
- Minimum of 3 yrs. experience in Quality System Administration in Medical Device Industry
- Good knowledge of ISO 13485, FDA QSR 21 CFR Part 820 regulatory standards, and the Medical Device Directive 93/42 EEC.
- Qualified Lead Auditor
- Experience in managing/participating in External Audits (customer and/or Regulatory body audits)
- Experience in completing Engineering Change processes.
For further information on this Quality Systems Assistant role in Leitrim please contact Cliona O'Malley on 091730022 / firstname.lastname@example.org
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