Design Quality Engineer

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

At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That's why we're not just transforming cancer care-we're changing lives. We introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day: "What would I do if this patient were my mom?" That question drives everything we do. But our mission doesn't stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare - driven by innovation, compassion, and purpose. Join us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.

Position Summary

The Design Quality Engineer is responsible for authoring Quality deliverables, reviewing, maintaining the Design history file (DHF) and Risk File records, ensuring compliance with all applicable regulations. The position will work in collaboration with the Development, Laboratory Operations, Regulatory Affairs, project/program management, and other cross-functional teams throughout the product lifecycle activities supporting vitro diagnostics (IVDs) and Laboratory Developed Tests (LDTs), at Caris Life Sciences.

Job 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.

Required 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.

Preferred Qualifications

• Design controls experience, including DHF, traceability matrices, V&V documentation, and design review records is a plus.
• 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.

Physical Demands

• Ability to lift routine office supplies and use standard office equipment.
• Ability to sit for extended periods of time.
• Majority of work performed in a desk or cubicle environment, with occasional exposure to laboratory environments including noise, fumes, and bio-hazardous materials.

Training

• All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

Other

• Travel- 10% may be required

Conditions of Employment

Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check ( applicable for certain positions) and reference verification.

This job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Caris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.