Senior Design Quality Engineer — Design Controls & Risk

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

Job summary

Caris Life Sciences, Ltd. in Phoenix, AZ, is seeking a Senior Design Quality Engineer responsible for overseeing design controls and risk management activities. The role focuses on ensuring compliance with regulations while guiding product development teams on design controls.

The ideal candidate will possess a Bachelor’s degree in engineering and 4+ years of relevant experience. You'll work closely with cross-functional teams and may need to adapt to a dynamic work environment with potential travel.

Qualifications

• Minimum 4+ years of hands-on experience in design controls or risk management.
• Experience with ISO 13485, CFR Part 820, and ISO 14971.
• Ability to prepare technical reports and V&V protocols.

Responsibilities

• Create and maintain the Design and Development Plan for new projects.
• Review and approve DHF deliverables, ensuring compliance.
• Support design reviews and manage deviations in verification activities.

Skills

Design controls

Risk management

Technical documentation

ISO 13485

CFR Part 820

Education

Bachelor’s degree in engineering or related field

Tools

eQMS

Job description

Caris Life Sciences, Ltd. in Phoenix, AZ, is seeking a Senior Design Quality Engineer responsible for overseeing design controls and risk management activities. The role focuses on ensuring compliance with regulations while guiding product development teams on design controls.

The ideal candidate will possess a Bachelor’s degree in engineering and 4+ years of relevant experience. You'll work closely with cross-functional teams and may need to adapt to a dynamic work environment with potential travel.