Senior Design Quality Engineer

The Senior Design Quality Engineer is primarily responsible for supporting the Design Controls, risk

management activities, and maintaining the Design history file (DHF), ensuring compliance with all

applicable regulations This role partners closely with assay development, laboratory operations,

regulatory affairs, and quality teams throughout the product lifecycle.

Job Responsibilities

• Responsible for creating the Design and Development Plan (DDP) for the new development projects, updating the DDP throughout the lifecycle of the product.

• Create and maintain risk management file with support from cross-functional teams including risk management plan/report, hazard analysis, dFMEA, uFMEA.

• Provide mentorship, guidance and training to the product development teams new to design controls and risk management processes.

• Review and approve DHF deliverables including V&V Plan/Protocol/Reports, requirements, and specifications.

• Manage deviation and issues for the verification and validation activities.

• Support design reviews and design transfer activities including process validations, pFMEA and DMR.

• Support design changes and post market activities, for example change controls and corrective and preventive actions (CAPA) to ensure product safety.

• Perform risk assessments for the regulatory submissions.

• Participate in process improvement initiatives as necessary, performing gap analysis and risk communication.

• May work on special projects as needed in regard to Design Controls, + All job specific, safety, and compliance training are assigned based on the job functions associated with this employee.

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

• Minimum 4+ years of hands-on experience, or relevant comparable background.

• The ability to prepare and understand technical documentation such as technical reports, verification and validation protocols and reports.

• Working knowledge of design controls, risk management and product development processes.

• Experience with ISO 13485, CFR Part 820, ISO 14971.

• Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems.

Preferred Qualifications

• ISO 15189, CAP/CLIA and GCP/GCLP preferred.

• Adaptable to fast-paced, dynamic work environment with shifting demands.

• Experience working with eQMS.

• Experience in supporting regulatory inspections

Physical Demands

• Employee may be required to lift routine office supplies and use standard office equipment.

• Ability to sit for extended periods of time.

• Majority of work is performed in a desk/cubicle environment, but at times, may have exposure to high noise levels in the data center, fumes and bio-hazardous material in the lab environment.

• Travel may be required for up to 10% of the time.

Caris Life Sciences (Phoenix, AZ)

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., Caris Life Sciences is a leading innovator in molecular science and artificial intelligence focused on fulfilling the promise of precision medicine through quality and innovation.

Caris is committed to quality and excellence at our state-of-the-art laboratories. Learn more about our tissue lab and the advanced technologies that are helping improve the lives of cancer patients.