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  • DUBLIN 2
  • Job reference number:15450312
  • Client ID:RI/AM16854
  • Posted on:10-JUN-2019
  • Location:WATERFORD
  • Job type:PERMANENT

Shift Quality Engineer - County Waterford.

Principal Responsibilities of this position:
• Liaise with shift management to manage the Manufacturing operation to provide the required volume output per shift which complies with all quality and regulatory requirements
• Determine appropriate lot disposition decisions on a shift by shift basis
• Manage, review & approve any non-conformances that may occur
• Provide quality oversight for manufacturing, including approval of validation documentation, updating PFMEA's, manage CAPA activity & continuous improvement
• Act as the MQM interface with Operations and engineering functions.
• Disposition product as appropriate & manage any non-conformance activity
• Highlight relevant issues and participate / lead resolution
• Understand and review Validation documentation, Change Requests, Design and Process FMEA’s
• Participate in Quality System Continuous Improvement activities
• Ensure regulatory compliance to GMP’s of applicable medical device regulatory agencies (eg, FDA, ISO and MDD) and internal documentation.
• Provide direction to ensure product quality is maintained at all stages of the manufacturing operation.

Interested applicants should have:
Minimum 3 years’ experience in a regulated pharmaceutical/medical device environment
• Manufacturing quality experience desirable
• Full understanding of the requirements of the Regulatory Standards
• Experience in Quality auditing an advantage
• Experience in using Microsoft Office products
• Experience of working in a team environment
• Third level Qualification in Science or Engineering
• Statistics/Six Sigma qualification an advantage
• Good communication skills
• The ability to motivate and influence people
• Self-starter, highly motivated with the ability to prioritise
• High attention to detail

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