Description

Own quality compliance and design controls across the full medical device lifecycle, from planning through release.

This role is on-site.

Responsibilities

• Establish and maintain DHF, DMR, and DHR with full traceability from user needs to validation evidence.
• Lead risk management activities including hazard analysis, FMEA, and integration of controls into design.
• Provide quality oversight of software SDLC activities, ensuring compliance with IEC 62304.
• Review and approve design, software, and validation deliverables for audit readiness.
• Support CAPA, nonconformance investigations, and internal/external audits (FDA, ISO).

Required Skills

• 10+ years of experience in Quality Engineering for regulated medical device development (Class II/III preferred).
• Strong hands-on experience with design controls, DHF management, and traceability.
• Working knowledge of 21 CFR 820, ISO 13485, ISO 14971, and IEC 62304.
• Experience supporting software quality within the SDLC and software risk management.
• Proven experience with FMEA, hazard analysis, and risk management tools.
• Experience supporting audits and regulatory submissions (IDE, PMA, EU MDR).
• Proficiency with eQMS/PLM tools and defect/CAPA management processes.

Preferred Skills

• Bachelor's degree in a relevant technical field.
• Ability to defend design and quality documentation during regulatory reviews.

Key Skills

Education

Bachelor's degree