Senior Design Quality Engineer — ISO 13485 QMS Lead

Circadia; El Segundo (CA); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Stock options

Health/dental/vision coverage

401(k)

Paid time off

Job summary

Circadia Health in El Segundo, CA is seeking a Senior Design Quality Engineer to establish and lead our quality engineering processes from the ground up. You will build, implement, and scale our Quality Management System (QMS) in alignment with ISO 13485 and FDA QMSR, owning design controls across the product lifecycle.

This hands-on role requires startup‑savvy execution, strong collaboration with R&D, engineering, and regulatory teams, and a track record of driving compliant processes in

Qualifications

• Bachelor’s degree in a relevant engineering field.
• 5+ years of design quality engineering experience in medical devices or digital health.
• Direct experience building ISO 13485 QMS from scratch in a startup environment.

Responsibilities

• Lead the design, implementation, and roll-out of an ISO 13485‑compliant QMS.
• Own design controls, risk management, CAPA, complaint handling, and PMS processes across the product lifecycle.
• Support regulatory submissions (e.g., 510(k)) and maintain DHF documentation.
• Collaborate cross-functionally with R&D, Engineering, Customer Success, Ops and Clinical teams.

Skills

Design Controls

Risk Management

CAPA management

Complaint Handling

Post-Market Surveillance

QMS Implementation

FDA Submissions

Education

BSc in Biomedical/Software/Mechanical Eng

Job description

Circadia Health in El Segundo, CA is seeking a Senior Design Quality Engineer to establish and lead our quality engineering processes from the ground up. You will build, implement, and scale our Quality Management System (QMS) in alignment with ISO 13485 and FDA QMSR, owning design controls across the product lifecycle.

This hands-on role requires startup‑savvy execution, strong collaboration with R&D, engineering, and regulatory teams, and a track record of driving compliant processes in