Description

You serve as the quality lead for product development teams, ensuring compliance with design controls across all lifecycle phases.

This role is on-site.

Responsibilities

• Establish and maintain DHF, DMR, and DHR, ensuring complete traceability from user needs through verification and validation evidence.
• Lead risk management activities, including hazard analysis and FMEA, integrating risk controls into design and validation.
• Provide quality oversight of software SDLC activities, ensuring compliance with standards like IEC 62304.
• Review and approve design, software, and validation deliverables to ensure completeness, consistency, and audit readiness.
• Support CAPA, nonconformance investigations, root cause analysis, and internal/external audits (FDA, ISO).

Required Skills

• 10+ years of experience in Quality Engineering supporting regulated medical device development (Class II/III preferred).
• Strong hands-on experience with design controls, DHF management, and traceability in regulated environments.
• Working knowledge of 21 CFR 820, ISO 13485, ISO 14971, and IEC 62304.
• Experience supporting software quality within the SDLC and understanding of software risk management principles.
• Proven experience with risk management tools (FMEA, hazard analysis) and integration into product development.
• Experience supporting audits and regulatory submissions, with the ability to defend design and quality documentation.
• Experience with quality systems, eQMS/PLM tools, and defect/CAPA management processes.

Preferred Skills

• Experience contributing to regulatory submissions (IDE, PMA, EU MDR).

Key Skills

Education

Bachelor's degree