Quality Engineer - Castletroy, Co.
Limerick CREGG are currently seeking a Quality Engineer to oversee all phases of product realisation, including NPD, NPI, commercialization, and end-of-life processes.
You will lead quality decision-making, ensuring the effective implementation of QMS documentation and driving quality improvements across development and manufacturing.
Key Responsibilities: Ensure compliance with GMP and QMS requirements throughout development and manufacturing.
Troubleshoot quality issues, drive corrective actions, and monitor effectiveness.
Lead validation planning, risk assessments (pFMEA), and process improvements.
Oversee vendor and part approvals, process changes, and change notifications.
Collaborate with project teams on statistical techniques and visual controls for manufacturing processes.
Ensure alignment between customer specifications and internal processes.
Manage non-conforming materials, lead root cause analysis, and document CAPA actions.
Support internal, customer, and regulatory audits, ensuring compliance with all requirements.
Required Skills & Experience: Degree in Engineering, Quality, or a related discipline.
Full working knowledge of EN ISO 13485, GMP, FDA QSR (21 CFR Part 820).
Experience with process validations, FMEA, and technical report writing.
Proficient in statistical analysis and Lean principles.
Lean Six Sigma Green Belt certification is desirable.
Ability to drive projects to completion and lead cross-functional teams.
Strong communication and interpersonal skills, with the ability to influence stakeholders.
Benefits: Competitive salary Health Insurance Pension Performance bonus Interested in a Confidential Discussion?
For more information or to discuss this opportunity further, please contact: Brendan McMahon |Technical Recruitment Consultant Phone: Email: Skills: NPD NPI QMS End-of-Life processes GMP GDP Troubleshooting Benefits: Mobile phone Flexitime Paid Holidays Canteen Parking Pension Educational assistance