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Fulfilling the promise of precision medicine through quality and innovation.
Senior Staff Design Quality Engineer
Location
United States
Posted
128 days ago
Salary
$158K - $173K / year
Seniority
Senior
Job Description
Senior Staff Design Quality Engineer
Caris Life Sciences
• 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.
Job 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
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