Senior Quality Operations Engineer

About the Role

Join Neko Health, a pioneering health-tech company, to ensure the integrity and compliance of our innovative medical scanning technology by driving excellence in our Quality Management System (QMS).

Responsibilities

• Manage Document and Change Control processes, ensuring compliance and efficiency across the organization.
• Oversee Feedback & Complaints Management, guaranteeing timely escalation and resolution according to regulatory standards.
• Lead Non-Conformance (NC) and CAPA processes, driving thorough root cause analysis and effective corrective actions.
• Support and coordinate internal and external audits, including those from Notified Bodies and regulatory inspections.
• Manage Training Programs to ensure all employees meet required competency standards.
• Improve and optimize eQMS workflows to enhance usability, efficiency, and regulatory compliance.

Requirements

• 5+ years of experience in Quality Operations or QMS management specifically within the medical device industry.
• Deep, demonstrable knowledge of ISO 13485, FDA QSR (21 CFR 820), and EU MDR.
• Proven experience managing core QMS elements: Document Control, Change Control, Complaints, NC & CAPA, and Audits.
• Hands-on experience with electronic QMS (eQMS) workflows, coupled with a strong mindset for process optimization.
• Excellent problem-solving, organizational, and cross-functional communication skills.

Nice-to-Haves

• Experience with AI/ML-driven quality systems or automated quality processes.
• Familiarity with post-market surveillance activities and supplier quality management frameworks.

Role Impact

At Neko Health, you will directly shape the future of our digital QMS, ensuring that our commitment to patient safety and regulatory adherence scales effectively with our rapid technological advancements.