SaMD Design Quality Engineer

Roles & Responsibilities

• Provide quality oversight for SaMD product development, design controls, software lifecycle activities, verification/validation, release, and design transfer.
• Review and maintain traceability between user needs, requirements, risk controls, test cases, and results.
• Support Design History File (DHF) and technical documentation to ensure audit readiness.
• Facilitate ISO 14971 risk management activities, including hazard analysis, risk evaluation, control implementation, residual risk assessment, and cybersecurity reviews.
• Maintain Risk Management Files and ensure risk updates throughout the product lifecycle.
• Own or support key QMS processes including CAPA, complaint handling, nonconformance management, document control, and continuous improvement activities.
• Conduct investigations, root cause analysis, effectiveness checks, and compliance assessments within required timelines.
• Support internal audits, regulatory inspections, and external audits (FDA, Notified Body, MDSAP, ISO 13485).
• Perform gap assessments and integration activities for acquired products, QMS processes, and design documentation.
• Act as the quality representative for assigned product teams, provide compliance guidance, and escalate quality risks when required.

Minimum Qualifications, Education & Experience

• Bachelor's degree in a relevant discipline or equivalent experience.
• 3 to 8 years of experience in a regulated industry; medical device and SaMD experience preferred.
• Strong knowledge of EU MDR 2017/745, ISO 13485, ISO 14971, IEC 62304, IEC 82304, IEC 81001-5-1, FDA Quality System/Quality Management System requirements, 21 CFR Part 11, and 21 CFR Part 820.
• Working knowledge of software development lifecycles, Agile methodologies, and application of design controls within software development.
• Experience participating in regulatory, certification, or quality system audits is desirable.
• Excellent written and verbal communication skills with the ability to create clear, compliant, and defensible quality records.
• Strong attention to detail, organizational skills, and ability to manage multiple priorities