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Senior Quality Validation Engineer, Mayo



Mayo, Ireland 

Job Category:

Biotech/Pharma, Engineering, Science

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Job Description:

Team Horizon currently has an exciting opening for a Senior Quality Validation Engineer to join our North Mayo based medical device manufacturing facility. The successful candidate will provide Quality Engineering services for the Plant Value Stream and so contribute to the growth and profitability of the company. Develop and implement Master Validation Plans, Risk Assessments and lead QE activities in the Value Stream.

Why you should apply:

  • Join a company that’s committed to help healthcare professionals deliver better products and services, and to make life more rewarding and dignified for those who use their products.
  • The role is generously compensated, and attracts a competitive base salary and attractive benefits package.

What you will be doing:

  • Participate or liaise with the core team in evaluation of product concepts to determine potential manufacturing processes
  • Develop Master Validation Plans
  • Develop and complete DV/IQ/OQ/PQ protocols
  • Contribute to the development of FAT/SAT protocols
  • Execute Validation Protocols, root cause deviations and generate validation reports
  • Develop product specifications / drawings / quality plans in conjunction with NPD personnel
  • Provide QE support for New Product Development (NPD) projects
  • Process Risk Management / FMEA
  • Complete internal audits per the audit schedule
  • Co-ordinate and implement process capability analysis on catheter processes
  • Complete CAPA investigations
  • Lead Production System (HPS) audits for the department
  • Supervision of Quality Engineers and Associate Quality Engineers during project activities

What you need to apply:

  • Degree in Engineering/Science Discipline and Quality Engineering Qualification
  • Experience in statistical analysis / SPC / validation of automated equipment
  • 8 years’ experience in Medical Device Industry utilizing automated equipment
  • Experience of people management
  • Master’s degree in Engineering/Science Discipline an advantage
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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