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Fulfilling the promise of precision medicine through quality and innovation.
Staff Design Quality Engineer
Location
United States
Posted
128 days ago
Salary
$120K - $138K / year
Seniority
Lead
Job Description
Staff Design Quality Engineer
Caris Life Sciences
• Lead the Design Controls planning and maintain the Design history file (DHF). • Ensure compliance with all applicable regulations. • Collaborate with cross-functional teams throughout the product lifecycle. • Support management reviews and audits related to Design Controls and Risk Management. • Create and maintain risk management file with support from cross-functional teams. • Review and approve DHF deliverables including V&V Plan/Protocol/Reports, requirements, and specifications. • Manage deviation and issues for verification and validation activities. • Support design reviews and transfer activities including process validations, pFMEA and DMR. • Perform risk assessments for regulatory submissions.
Job 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
- Health insurance
- 401(k) matching
- Professional development opportunities
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