QA NCR Governance Engineer — Flexible Quality Leader

Vantive; Castlebar; Hybrid; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Competitive salary

Annual bonus

Pension

Health & wellbeing

Employee Assistance Programme

Life assurance

Income protection

Generous annual leave

Flexible working

Learning & development

Career progression

Global mobility

Recognition & rewards

Inclusive culture

Job summary

Vantive, a leading dialysis-focused company, is seeking a QA NCR Governance Engineer to oversee Non-Conformance Reports (NCRs) and CAPA activities across the site, ensuring GMP compliance and quality records integrity.

You will track NCRs to closure, perform trend analyses, host CRB meetings, and act as the SME for NCR/CAPA processes while delivering training and driving continuous improvement within the Quality Management System.

Qualifications

• Experience in Quality Assurance or Quality Systems.
• Experience in pharmaceutical/biotech/medical device regulated manufacturing.
• Strong communication and documentation skills.
• Analytical and problem-solving abilities.

Responsibilities

• Complete NCR and CAPA records in line with site procedures and quality standards.
• Track NCRs and CAPAs to closure, ensuring timelines and KPI targets are met.
• Conduct monthly NCR and exception trending analysis and communicate findings.
• Track and report site Quality and QCR metrics.
• Perform adequacy reviews of NCR and CAPA records.
• Escalate quality issues to the CRB as required.
• Host CRB meetings and weekly CAPA update boards.
• Serve as the site SME and point of contact for NCR and CAPA processes.
• Deliver training and guidance on NCR and CAPA management.
• Support continuous improvement initiatives within the Quality Management System.

Skills

Communication

Organisational skills

Stakeholder management

Technical writing

Documentation

Analytical thinking

Problem solving

Job description

Vantive, a leading dialysis-focused company, is seeking a QA NCR Governance Engineer to oversee Non-Conformance Reports (NCRs) and CAPA activities across the site, ensuring GMP compliance and quality records integrity.

You will track NCRs to closure, perform trend analyses, host CRB meetings, and act as the SME for NCR/CAPA processes while delivering training and driving continuous improvement within the Quality Management System.