QA Engineer Medical Devices jobs

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.

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.

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

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