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Quality System Assistant

Job Title: Quality System Assistant
Contract Type: Permanent
Location: Roscommon
REF: 86870
Job Published: almost 2 years ago

Job Description

Quality Systems Assistant

Our client has a permanent Quality Systems Assistant job available in Leitrim

Key responsibilities:
  • 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 /
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