Design Quality Engineer

Caris Life Sciences • Papago, AZ

2d

About The Position

The Design Quality Engineer authors quality deliverables and reviews and maintains Design History File (DHF) and Risk File records, ensuring compliance with applicable regulations. The role collaborates with Development, Laboratory Operations, Regulatory Affairs, project and program management, and other cross-functional teams throughout product lifecycle activities supporting in vitro diagnostics (IVDs) and Laboratory Developed Tests (LDTs) at Caris Life Sciences.

Requirements

• Bachelor’s degree in a scientific, engineering, or related field.
• 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.

Nice To Haves

• Design controls experience, including DHF, traceability matrices, verification and validation documentation, and design review records.
• Experience with medical device risk management (ISO 14971).
• Working knowledge of ISO 15189 and ISO 22367 requirements.
• Ability to adapt to a fast-paced, dynamic work environment with shifting priorities.
• Experience supporting oncology diagnostic development, LDT workflows, or molecular assay development.

Responsibilities

• Support new product development, design changes, and post-launch activities as the Quality representative on sustaining projects.
• Create technical records and review and approve Design History File documentation.
• Create and 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 the project schedule and work independently with minimal supervision.
• Support inspection readiness by providing risk management and DHF documentation and creating quality plans as needed.
• Support design changes by assessing and documenting risk impacts of product and process changes.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level