Caris Life Sciences

Senior Staff Design Quality Engineer

Caris Life Sciences

full-time

Posted on:

Location Type: Remote

Location: United States

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Salary

💰 $158,000 - $173,000 per year

Job Level

Senior

About the role

  • Lead planning and execution of new product development and design change projects with a focus on Design Controls and Risk Management activities.
  • Work effectively with cross-functional teams for the harmonization and consistency across several projects.
  • Take ownership of the processes (Design Controls and Risk Management).
  • Identify improvement opportunities and lead cross-functional teams to implement the process improvements.
  • Provide mentorship, guidance, and training to the product development teams.
  • Support the implementation of eQMS tools for design controls and risk management (eDHF).
  • Lead Design Reviews with participation from the core teams.
  • Provide review and approvals of DHF deliverables such as verification and validation plan, protocol/report, requirements, and specifications.
  • Lead creation of risk management file with support from the cross-functional product development teams, risk management plan/report, hazard analysis, dFMEA, uFMEA.
  • Maintain risk file in the post-market lifecycle phase.
  • Support design transfer activities including BOM and DMR.
  • Assist in regulatory inspection readiness activities and provide support during regulatory site inspections.
  • Participate in process improvement initiatives as necessary, performing gap analysis.
  • Perform root cause analysis, CAPA, closure of audit/inspection observations, and other QMS activities related to design controls and risk management.

Requirements

  • Minimum 10+ years of hands-on experience, or relevant comparable background
  • Advanced understanding of the ISO 13485, FDA QSR/21 CFR Part 820, ISO 14971
  • Basic understanding of the IEC 62304, 62366 standards
  • Technical expertise and understanding of IVD assays and data analysis tools
  • Experience in successfully leading new product development teams through design controls and risk management processes, including DHF documentation including product risk file.
  • Requires strong oral and written communication skills and interpersonal skills.
Benefits
  • Health insurance
  • 401(k)
  • Paid time off
  • Flexible work arrangements
Applicant Tracking System Keywords

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

Hard Skills & Tools
Design ControlsRisk ManagementDHF documentationrisk management planhazard analysisdFMEAuFMEAroot cause analysisCAPAdata analysis tools
Soft Skills
mentorshipguidancetrainingcommunication skillsinterpersonal skillsleadershipprocess improvementownershipcollaborationproblem-solving
Certifications
ISO 13485FDA QSR/21 CFR Part 820ISO 14971IEC 62304IEC 62366