Validation Engineer(Hybrid)

Our Medical Device Client in Mayo are hiring! We are looking to speak with Validation Engineers to develop and implement Validation Plans/Protocols/Reports, Risk Assessments and lead QE project and compliance activities in our Client’s expanding site. This position falls under Quality Assurance.

Key Responsibilities

• 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
• Contribute to 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 sealing processes
• Complete CAPA, Non-conforming material rejection and complaint investigations
• Lead Production System (HPS) assessments for the department

Key Requirements

• Level 8 Degree in Engineering/Science Discipline
• Experience in statistical analysis / SPC / validation of automated equipment
• 3 years’ experience in Medical Device Industry utilizing automated equipment

For further information on this role in please contact Michael Marvin  on 0864409255 or email sourcing@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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