Medical Device Quality Engineer

A company is looking for a Senior Principal Software Quality Engineer.

Key Responsibilities

Provide Quality Engineering leadership for software and hardware product development teams, ensuring compliance with industry standards and regulations

Lead the development and maintenance of the Risk Management File (RMF), including risk management plans and hazards analysis

Review and approve Design History Files (DHF) and associated documentation

Required Qualifications

8+ years of progressive Quality Engineering experience in the Medical Device industry

Deep understanding of FDA CFR 820, ISO 13485, ISO 14971, IEC 60601, IEC 62304, and IEC 62366 standards

Experience with design, verification, validation, and testing of electromechanical medical devices and software

Proficiency in statistical tools and quality engineering tools for process improvement