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Neko Health · 1 month ago

Senior Quality Engineer - Operations

United States

Full-time

Remote

Senior Level

5+ years exp

Neko Health is a Swedish healthcare technology company focused on preventative health and early detection. As a Senior Quality Operations Engineer, you will ensure the effectiveness of the Quality Management System (QMS) and oversee compliance with various regulations while managing critical quality processes.

Artificial Intelligence (AI)Health CareHospital

Responsibilities

Manage Document and Change Control, ensuring compliance and efficiency

Oversee Feedback & Complaints Management, ensuring timely escalation and resolution

Lead Non-Conformance (NC) and CAPA processes, driving root cause analysis and corrective actions

Support internal and external audits, including Notified Body and regulatory inspections

Manage Training Programs, ensuring employees meet competency requirements

Improve and optimize eQMS workflows to enhance usability and compliance

Qualification

Quality Management SystemISO 13485FDA QSREU MDRDocument ControlChange ControlComplaints ManagementNon-Conformance ManagementCAPA ProcessesAuditsTraining Management SystemsEQMS OptimizationAI/ML Quality SystemsPost-Market SurveillanceSupplier Quality ManagementProblem-Solving SkillsOrganizational SkillsCommunication Skills