Design Quality Engineer

Caris Life Sciences

. Author Quality deliverables .

Posted 10/16/2026full-timeUnited StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Management Systems, including ISO 13485 and ISO 14971, while effectively collaborating with cross-functional teams to support product development and compliance. Proficient in risk management and technical documentation, ensuring adherence to regulatory requirements throughout the product lifecycle.

Highest-signal resume keywords

ISO 13485 Quality Management SystemMedical Device Risk Management (ISO 14971)Design Controls ExperienceProduct Development ProcessesOncology Diagnostic Development

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Risk AssessmentsDesign History File (DHF)Traceability MatricesVerification and Validation (V&V) DocumentationDesign Review RecordsTechnical Records CreationQuality Plans DevelopmentRegulatory ComplianceLaboratory Operations SupportProduct Lifecycle Activities

Soft Skills

AdaptabilityCollaborationCommunicationProblem-SolvingAttention to Detail

Industry Keywords

IVDDiagnosticsBiotechClinical LaboratoryLDT WorkflowsMolecular Assay DevelopmentISO 15189ISO 22367Quality EventsNonconformances

About the role

Key responsibilities & impact

Author Quality deliverables
Review and maintain Design History File (DHF) and Risk File records
Ensure compliance with applicable regulations
Collaborate with Development, Laboratory Operations, Regulatory Affairs, project/program management, and other cross-functional teams throughout product lifecycle activities
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 Files
Create and maintain Risk Management records aligned 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
Support inspection readiness by providing risk management/DHF documentation and creating quality plans as needed
Support design changes by assessing and documenting risk impact of product and process changes
Work primarily in a desk or cubicle environment, with occasional exposure to laboratory environments including noise, fumes, and bio-hazardous materials

Requirements

What you’ll need

Bachelor’s degree in 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
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
Ability to lift routine office supplies and use standard office equipment
Ability to sit for extended periods of time
Willingness/ability to travel up to 10%
Individual must successfully complete pre-employment process, including criminal background check, drug screening, credit check (applicable for certain positions), and reference verification

Benefits

Comp & perks

Equal opportunity employer
Pre-employment process including criminal background check, drug screening, credit check (applicable for certain positions), and reference verification
Job-specific, safety, and compliance training assigned based on job functions