Caris Life Sciences

Staff Design Quality Engineer

Caris Life Sciences

full-time

Posted on:

Location Type: Hybrid

Location: Phoenix • Arizona • United States

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Job Level

Lead

About the role

  • 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 deviations and corrective and preventive actions (CAPA) to ensure product safety.
  • Perform risk assessments for the regulatory submissions.
  • Support the implementation of eQMS tools for design controls and risk management (eDHF).
  • Support Management reviews and internal/external audits as a subject matter expert.
  • Participate in process improvement initiatives as necessary, performing gap analysis.
  • Perform complaint investigations, root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to design controls and risk management.

Requirements

  • Bachelor’s degree in engineering, scientific or related field.
  • Minimum 6+ years of hands-on experience, or relevant comparable background.
  • Hands-on experience with ISO 13485, FDA QSR/21 CFR Part 820, ISO 14971 IVDR.
  • Technical expertise and understanding of IVD assays and data analysis tools.
  • Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems.
  • Experience in successfully leading new product development teams through design controls and risk management processes, including DHF documentation including product risk file.
Benefits
  • Job may require after-hours response to emergency issues
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
risk managementdesign controlsdFMEAuFMEAV&V Planprocess validationpFMEACAPAroot cause analysisdata analysis
Soft Skills
mentorshipguidancetrainingcross-functional collaborationprocess improvementproblem-solvingcommunicationleadership