Impactful Design Quality Engineer for IVD Diagnostics

Caris Life Sciences; Arizona; On-site; USD 90,000 - 130,000; Full time

Job summary

Caris Life Sciences is seeking a Design Quality Engineer in Tempe, AZ or Irving, TX to support new product development and sustaining activities. You will author and maintain DHF, perform risk assessments, and help ensure regulatory compliance across IVDs and LDTs.

The role requires a Bachelor’s degree in a scientific/engineering field and 0–4 years of relevant experience with ISO 13485 and design controls. Travel and cross-functional collaboration are part of the job.

Qualifications

• Bachelor's degree in scientific or engineering field with 0–4 years in product development, IVD, diagnostics, biotech, or clinical labs.
• Understanding of ISO 13485 quality management system requirements.
• Design controls experience and DHF/traceability knowledge is a plus.

Responsibilities

• Support New Product development and post-launch activities as the Quality representative on sustaining projects.
• Create and maintain Design History File and Risk Management records.
• Assist with risk assessments for quality events, nonconformances, and complaints.
• Support inspection readiness and quality planning as needed.

Skills

Quality assurance

Regulatory awareness

Independent working

Education

Bachelor’s degree in science/engineering

Tools

DHF management

Risk management tools

Job description

Caris Life Sciences is seeking a Design Quality Engineer in Tempe, AZ or Irving, TX to support new product development and sustaining activities. You will author and maintain DHF, perform risk assessments, and help ensure regulatory compliance across IVDs and LDTs.

The role requires a Bachelor’s degree in a scientific/engineering field and 0–4 years of relevant experience with ISO 13485 and design controls. Travel and cross-functional collaboration are part of the job.