Senior Quality Assurance Engineer - Hybrid, 12-Month Contract

PE Global; Athlone; Hybrid; EUR 65,000 - 90,000; Full time

Benefits offered by this job

Hybrid working

Job summary

PE Global are recruiting a Senior Quality Assurance Engineer for a client based in Athlone. This is an initial 12-month contract role with hybrid working options.

The role represents the Quality function in site management meetings and supports the Manufacturing Quality Lead in daily activities. Responsibilities include leading validations, risk assessments, change controls, and regulatory audits (ISO/FDA).

Qualifications

• Engineering or Science degree required.
• Experience with problem solving techniques.
• Familiarity with FMEA and root cause analysis tools.
• Ability to communicate highly technical information clearly to both technical and non-technical colleagues.

Responsibilities

• Represent Quality function in Site Management meetings as required.
• Lead and guide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.
• Review and/or develop and execute facility, software, process and equipment validations and risk management documents.
• Provide guidance on change controls for validation impact.
• Use knowledge of statistics to assist with validation developments and process improvements.
• Lead the analysis and resolution of problems that may reduce the efficient running of production lines.
• Facilitate and lead external regulatory body audits (ISO and FDA).
• Support development and improvement of site Quality Metrics.
• Ensure compliance with CGMP and EHS policies.

Skills

Pareto charts

Trend charts

FMEA

Root cause analysis

Problem solving

Technical communication

Education

Engineering or Science Degree

Job description

PE Global are recruiting a Senior Quality Assurance Engineer for a client based in Athlone. This is an initial 12-month contract role with hybrid working options.

The role represents the Quality function in site management meetings and supports the Manufacturing Quality Lead in daily activities. Responsibilities include leading validations, risk assessments, change controls, and regulatory audits (ISO/FDA).