ISO 13485 QMS Lead: Senior Design Quality Engineer

Circadiahealth; El Segundo (CA); On-site; USD 140,000 - 200,000; Full time

Job summary

Circadia Health is seeking a Senior Design Quality Engineer to build and lead our QMS from the ground up, aligning with ISO 13485 and FDA QMSR. You will own design controls, CAPA, complaint handling, and post-market surveillance across Circadia products.

The ideal candidate brings 5+ years in medical device or digital health design quality engineering, startup experience, and strong regulatory submission capabilities.

Qualifications

• Bachelor’s degree in a technical field (Biomedical/Software/Mechanical).
• 5+ years in design quality engineering within medical devices or digital health.
• Experience building and implementing ISO 13485 QMS and FDA QMSR knowledge.

Responsibilities

• Lead QMS architecture, implement ISO 13485-compliant systems, and ensure audit readiness.
• Direct complaint handling, root-cause analysis, CAPA, and nonconformance activities.
• Oversee post-market surveillance programs and PMS reporting.
• Support design controls, DHF maintenance, risk management, and validation documentation.
• Assist with FDA submissions and compile testing documentation; coordinate cross-functional efforts.

Skills

QMS implementation

Design Controls

Risk Management (ISO 14971)

CAPA management

Complaint Handling

Post-Market Surveillance (PMS)

Regulatory Submissions

Cross-Functional Collaboration

Human factors validation

Cybersecurity testing coordination

Third-party testing documentation

Education

Bachelor's degree: Biomedical Engineering

Bachelor's degree: Software Engineering

Bachelor's degree: Mechanical Engineering

Tools

CQE

CSQE

Six Sigma Green/Black Belt

Job description

Circadia Health is seeking a Senior Design Quality Engineer to build and lead our QMS from the ground up, aligning with ISO 13485 and FDA QMSR. You will own design controls, CAPA, complaint handling, and post-market surveillance across Circadia products.

The ideal candidate brings 5+ years in medical device or digital health design quality engineering, startup experience, and strong regulatory submission capabilities.