Design Quality Engineer – IVD & Risk Management Specialist

Caris Life Sciences; Tempe (AZ); On-site; USD 80,000 - 110,000; Full time

Job summary

Caris Life Sciences in Tempe, AZ is seeking a Design Quality Engineer who will author quality deliverables, maintain the Design History File (DHF) and Risk File records, and ensure compliance across the product lifecycle for in vitro diagnostics (IVDs) and Laboratory Developed Tests (LDTs).

You will collaborate with Development, Regulatory Affairs, and Laboratory Operations to support new product development, risk management, design changes, and inspection readiness in a fast-paced

Qualifications

• Bachelor's degree in scientific, engineering or related field; 0–4 years in product development, IVD, diagnostics, biotech, or clinical lab environments.
• Understanding of ISO 13485 quality management system requirements.
• Design controls experience and DHF, traceability matrices, V&V documentation is a plus.

Responsibilities

• Author quality deliverables and maintain Design History File (DHF) and Risk File records.
• Support New Product development and post-launch activities as the Quality representative on sustaining projects.
• Create and review Technical records; approve Design History File.
• Maintain Risk Management records in alignment with quality system and regulatory requirements including design and use risk assessments.
• Perform risk assessments for Quality Events, nonconformances and complaints.
• Plan and coordinate work according to project schedules; ensure inspection readiness.

Skills

Product development knowledge

Quality systems

ISO 13485 awareness

Risk management

LDT/IVD experience

Adaptability

Molecular assay development

Education

Bachelor's degree in science/engineering

Job description

Caris Life Sciences in Tempe, AZ is seeking a Design Quality Engineer who will author quality deliverables, maintain the Design History File (DHF) and Risk File records, and ensure compliance across the product lifecycle for in vitro diagnostics (IVDs) and Laboratory Developed Tests (LDTs).

You will collaborate with Development, Regulatory Affairs, and Laboratory Operations to support new product development, risk management, design changes, and inspection readiness in a fast-paced