Design Quality Engineer — IVD & Risk Mgmt

Caris Life Sciences; Irving (TX); On-site; USD 90,000 - 120,000; Full time

Job summary

Caris Life Sciences is seeking a Design Quality Engineer to author quality deliverables, maintain the Design History File (DHF) and Risk File, and ensure compliance with applicable regulations across the product lifecycle for IVDs and LDTs.

The role collaborates with Development, Regulatory Affairs, Laboratory Operations, and cross-functional teams to support new product development, design changes, and post-launch activities. Strong knowledge of ISO 13485 is essential.

Qualifications

• Bachelor’s degree in scientific, engineering or related field with 0-4 years of experience in product development, IVD, diagnostics, biotech, or clinical laboratory environments.
• Working knowledge of product development processes.
• Understanding of ISO 13485 quality management system requirements.

Responsibilities

• Support New Product development, design changes and post launch activities as the Quality representative on sustaining projects.
• Create Technical records, review and approve Design History File
• Create and maintain the Risk Management records in alignment with quality system and regulatory requirements including design and use risk assessments.
• Perform Risk assessment for the Quality Events, Nonconformance and complaints.
• Able to work independently with minimal supervision.
• Can plan and coordinate work according to the project schedule.
• Support inspection readiness by providing risk management /DHF documentation and creating quality plan as needed.
• Support design changes to assess and document risk impact of product and process changes.

Skills

Product development

ISO 13485

Education

Bachelor’s degree in scientific, engineering or related field

Job description

Caris Life Sciences is seeking a Design Quality Engineer to author quality deliverables, maintain the Design History File (DHF) and Risk File, and ensure compliance with applicable regulations across the product lifecycle for IVDs and LDTs.

The role collaborates with Development, Regulatory Affairs, Laboratory Operations, and cross-functional teams to support new product development, design changes, and post-launch activities. Strong knowledge of ISO 13485 is essential.