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Fulfilling the promise of precision medicine through quality and innovation.
Senior Design Quality Engineer
Location
United States
Posted
127 days ago
Salary
$106K - $112K / year
Seniority
Senior
Job Description
Senior Design Quality Engineer
Caris Life Sciences
• Responsible for creating the Design and Development Plan (DDP) for new development projects • Create and maintain risk management file with support from cross-functional teams include risk management plan/report, hazard analysis, dFMEA, uFMEA. • Provide mentorship, guidance and training to 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 verification and validation activities. • Support design reviews and design transfer activities including process validations, pFMEA and DMR. • Support design changes and post market activities, ensuring product safety. • Perform risk assessments for regulatory submissions. • Participate in process improvement initiatives as necessary, performing gap analysis and risk communication.
Job Requirements
- Bachelor’s degree in engineering, scientific or related field
- Minimum 4+ years of hands-on experience, or relevant comparable background.
- The ability to prepare and understand technical documentation such as technical reports, verification and validation protocols and reports.
- Working knowledge of design controls, risk management and product development processes.
- Experience with ISO 13485, CFR Part 820, ISO 14971.
- Working knowledge of and proficiency in U.S. and International medical device regulations and implementing Quality Systems.
Benefits
- Health insurance
- 401(k)
- Paid time off
- Flexibility in work arrangements
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