Impactful Design Quality Engineer for IVD/Diagnostics

Caris Life Sciences; Papago (AZ); On-site; USD 85,000 - 110,000; Full time

Job summary

Caris Life Sciences is seeking a Design Quality Engineer to lead quality deliverables, maintain the DHF and Risk File records, and ensure regulatory compliance across the product lifecycle for IVDs and LDTs.

The role collaborates with Development, Laboratory Operations, Regulatory Affairs and cross-functional teams to support design changes, risk assessments, and post-launch activities in a fast-paced diagnostic environment.

Qualifications

• Bachelor’s degree in scientific, engineering or related field with 0–4 years of experience in IVD/diagnostics/biotech environments.
• Strong understanding of product development processes.
• Knowledge of ISO 13485 QMS requirements.

Responsibilities

• Author and maintain design history file (DHF) and risk file records.
• Collaborate with Development, Regulatory Affairs and cross-functional teams.
• Support New Product development, design changes and post-launch activities as Quality representative.
• Perform risk assessments for quality events, nonconformance and complaints.
• Ensure inspection readiness with risk management and DHF documentation.

Skills

Quality systems

Product development

Regulatory knowledge

Documentation

Education

Bachelor’s degree in science/engineering

Tools

ISO 14971

ISO 13485

ISO 15189

ISO 22367

Job description

Caris Life Sciences is seeking a Design Quality Engineer to lead quality deliverables, maintain the DHF and Risk File records, and ensure regulatory compliance across the product lifecycle for IVDs and LDTs.

The role collaborates with Development, Laboratory Operations, Regulatory Affairs and cross-functional teams to support design changes, risk assessments, and post-launch activities in a fast-paced diagnostic environment.