CVRx | Barostim

QA Engineer

• Lead quality and reliability support for programmers, implantable pulse generators, and test systems, providing hands‑on support for both production operations and product development initiatives.
• Drive continuous improvement in product quality and reliability by identifying and implementing process enhancements and product design improvements.
• Own and manage risk management documentation, including reliability, risk and hazard analyses, including Failure Modes and Effects Analyses (FMEAs).
• Provide quality leadership by authoring, reviewing, and approving design and development documentation, protocols, and reports for hardware, software, and firmware.
• Develop, review, and approve test plans and test reports supporting production testing, screening activities, and qualification efforts.
• Lead investigations into returned products, field issues, complaints, and clinical adverse events, performing root cause analysis, health hazard evaluations, and supporting CAPA activities with thorough documentation.
• Generate, review, and approve Nonconforming Material Reports (NMRs), deviations, product holds, and issue documentation, ensuring effective quality and reliability support for manufacturing operations.
• Generate, review, and approve process evaluations, characterizations, qualifications, and validations, ensuring processes are capable, compliant, and sustainable.
• Plan, coordinate, and oversee supplier and component selection and qualification, ensuring reliable and compliant supply chains.
• Provide statistical analysis and sample size justification to support production and development qualification and validation testing.
• Maintain ownership or provide oversight for assigned CAPA activities, ensuring timely, effective, and well‑documented resolution of quality issues.
• Generate, review, and approve non‑product software documentation, including specifications, validation, and release records supporting field support, manufacturing, and development software applications.
• Develop working knowledge of internal audit practices and support internal audits to ensure compliance with applicable regulations and CVRx standard operating procedures (SOPs).
• Plan, perform, or support Gage Repeatability and Reproducibility (R&R) studies, documenting results to ensure measurement system capability and reliability.
• Support the organization through additional quality‑related responsibilities, as assigned, contributing to team objectives and business needs.

Senior Quality Engineer