Senior Quality Engineer – Operations

About the Role

Location: Stockholm, Sweden or Europe | Full-time Remote or Hybrid

At Neko Health, we develop innovative medical technologies that enhance healthcare outcomes. As a Senior Quality Operations Engineer, you will play a key role in ensuring our Quality Management System (QMS) operates effectively and evolves to meet business and regulatory needs. You will oversee document and change control, feedback & complaints management, NC & CAPA, audits, training, and eQMS workflows, ensuring compliance with ISO 13485, EU MDR, and FDA regulations.

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.

Requirements:

• 5+ years of experience in Quality Operations or QMS management within the medical device industry.
• Strong knowledge of ISO 13485, FDA QSR (21 CFR 820), and EU MDR.
• Experience managing Document Control, Change Control, Complaints, NC & CAPA, and Audits.
• Familiarity with Training Management systems and eQMS optimization.
• Hands-on experience with electronic QMS (eQMS) workflows, with a mindset for process optimization.
• Strong problem-solving, organizational, and communication skills.

Nice to Have

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

Why Join Us?

At Neko Health, you’ll help shape the future of quality operations and digital QMS, ensuring compliance while driving efficiency.
If you’re passionate about QMS operations, continuous improvement, and regulatory compliance, we’d love to hear from you!