QA CAPA/ NCR Investigation Engineer

Vantive is a vital organ therapy company on a mission to extend lives and 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 possibilities.

The QA CAPA Investigation Engineer is responsible for managing non-conformance and corrective and preventive action (CAPA) activities to ensure compliance with internal quality systems, regulatory requirements, and global KPI targets. The role involves leading investigations, facilitating cross-functional teams, identifying root causes, implementing effective corrective actions, and ensuring timely closure of quality records.

Key Responsibilities

Non-Conformance Management

Complete and manage Non-Conformance Reports (NCRs) in accordance with company procedures, global KPI metrics, and applicable regulatory requirements.

Conduct thorough investigations into quality issues, deviations, and non-conformances.

Ensure investigations are completed within established timelines and quality standards.

Review investigation data and supporting documentation for completeness and accuracy.

CAPA Management

Create, initiate, and facilitate the completion of CAPA records to support quality system effectiveness.

Ensure CAPA activities are appropriately documented, justified, implemented, and verified.

Monitor CAPA progress and drive timely completion to meet KPI targets.

Assess the effectiveness of implemented corrective and preventive actions.

Investigation Leadership

Chair and facilitate cross-functional investigation meetings involving Manufacturing, Engineering, Validation, QC, Regulatory Affairs, Supply Chain, and other relevant stakeholders.

Coordinate investigation activities and ensure actions are assigned, tracked, and completed.

Apply structured problem-solving methodologies to identify root causes and drive sustainable improvements.

Quality Systems Compliance

Review and approve NCR and CAPA records to ensure compliance with internal procedures and regulatory expectations.

Support internal and external audits by providing investigation and CAPA documentation as required.

Contribute to continuous improvement initiatives within the Quality Management System (QMS).

Ensure all activities comply with GMP, company policies, and regulatory standards.

Qualifications

Bachelor's Degree (Level 8 or equivalent) in Science, Engineering, Quality, Pharmaceutical Sciences, or a related discipline.

Experience in the pharmaceutical, medical device, biotechnology, or regulated manufacturing industry.

Experience within a Quality Assurance or Quality Systems environment.

Employee Benefits

Competitive salary and annual compensation reviews

Performance-based bonus opportunities

Pension/retirement savings scheme

Comprehensive health and wellbeing programme

Employee Assistance Programme (EAP)

Life assurance and income protection benefits

Generous annual leave entitlement plus public holidays

Flexible and hybrid working opportunities (role dependent)

Paid family leave and support policies

Career development and continuous learning opportunities

Internal mobility and global career pathways

Professional training and educational assistance

Recognition and reward programmes

Employee wellness initiatives and wellbeing resources

Inclusive, collaborative, and diverse working environment

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.