QA CAPA/ NCR Governance Engineer

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 is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients- that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

QA NCR Governance Engineer

The QA NCR Governance Engineer is responsible for the oversight and governance of Non-Conformance Reports (NCRs) and CAPA activities across the site. The role ensures quality records are effectively managed, KPI targets are achieved, and compliance with GMP and regulatory requirements is maintained.

Key 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 Corrective Review Board (CRB) as required.
• Host CRB meetings and weekly CAPA update boards.
• Serve as the site subject matter expert 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.

Qualifications & Experience

lExperience within the pharmaceutical, biotechnology, medical device, or regulated manufacturing industry.

• Experience in a Quality Assurance or Quality Systems role.
• Strong communication, organisational, and stakeholder management skills.
• Excellent technical writing and documentation skills.
• Strong analytical and problem-solving abilities.

Benefits at Vantive

• Competitive salary and annual bonus opportunity
• Pension scheme
• Health and wellbeing programmes
• Employee Assistance Programme (EAP)
• Life assurance and income protection
• Generous annual leave entitlement
• Flexible working arrangements (role dependent)
• Learning and development opportunities
• Internal career progression and global mobility opportunities
• Recognition and reward programmes
• Inclusive and collaborative working environment

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally.