Senior Quality Assurance Engineer

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 for a Senior Quality Assurance Engineer for our client based in Athlone. This is an initial 12-month contract role. Hybrid working options.

Job Responsibilities

• Represent Quality function in Site Management meetings as required
• Will act as a delegate for site Manufacturing Quality Lead
• Liaise with Manufacturing Engineering on the completion of risk assessment, Work Instruction updates, and FMEA’s for any product line extensions, process improvements for both new and existing products.
• 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
• Work with Manufacturing Engineering to develop strategy and sampling plans, for completion of validation for new and existing product lines
• Lead the analysis and resolution of problems that may reduce the efficient running of production lines.
• Lead and guide quality support to Manufacturing Engineering with NCMR and CAPA investigation, processing and disposition.
• Ensure continuous compliance for Product Manufacturing, Packaging and Labeling.
• Perform and lead Internal Audits.
• Facilitate and lead external regulatory body audits, i.e., ISO and FDA
• Support the development, analysis and improvement of site Quality Metrics.
• Will abide to Environmental, Health and Safety (EHS) Policies and any relevant other EHS documentation.
• Will comply with all relevant training required and adhere to relevant associated documentation.
• Follow strict adherence to the requirements of CGMP.
• Lead the enhancement of compliance initiatives for areas of responsibility.

Education & Experience

• Engineering or Science Degree
• Familiarity with statistical tools such as Pareto charts and trend charts.
• Familiarity with FMEA’s (Failure Mode and Effects Analysis) and root cause analysis tools.
• Experience with problem solving techniques
• Ability to effectively communicate highly technical information, both verbally and in writing, to both non-technical and technical associates

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland****