Supplier Quality Engineer

Permanent
​​Leitrim
 Role
Supplier Quality Engineer
 
Overview
  • Prepare, maintain and review supplier quality procedures to ensure compliance with customer and regulatory requirements.
  • Complete the supplier performance review process. Generate appropriate performance metrics, and drive resolution of issues
  • Develop and execute the global supplier audit schedule. Travel to supplier facilities to conduct audits and to enhance effectiveness and capabilities
  • Process and implement supplier changes through the supplier change notification process
  • Support Supply Chain Manager in the development of new suppliers or existing suppliers of new components, to improve reliability and/or reduce cost
  • Lead briefings and technical meetings for internal and external representatives
  • Participation in the Plant Corrective Action Programme
  • Participation in the Internal Quality Audit Programme
  • Ensuring that product introductions & change controls are effectively managed in accordance with the requirements of ISO 13485, MDD 93/42/EEC & MDR 2017/745.
  • Participation in the new product introductions programmes to ensure that they are effectively introduced in accordance with the requirements of ISO 13845.  Generation of Product Technical Files & associated studies in accordance with MDD 93/42/EEC & MDR 2017/745 when appropriate.
  • 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:
  • Third level qualification in Engineering/Manufacturing/Quality with emphasis on Medical Device
  • 2-3 years’ experience as Quality Engineer in Medical Device/Pharmaceutical Environment is desirable
  • Fully PC literate, use/knowledge of Minitab would be beneficial.
  • Strong CAPA experience
  • Strong working knowledge of FDA and ISO Quality systems for Medical device companies desirable
  • Demonstrated excellent organizational skills and ability to work on own initiative essential