Caris Life SciencesRemote
Senior Design Quality Engineer
United States
Full Time
1 hour ago
$106,000 - $112,000 USD
H1B Sponsor
Key skills
Design controlsRisk managementISO 13485CFR Part 820Product development processesISO 14971eQMS experienceRegulatory inspectionsMentorshipGCPRisk ManagementCommunication
About this role
Caris Life Sciences is a company dedicated to transforming cancer care and improving human health through precision medicine and innovation. The Senior Design Quality Engineer will support design controls and risk management activities, ensuring compliance with regulations while partnering with various teams throughout the product lifecycle.
Responsibilities:
- 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 change controls and corrective and preventive actions (CAPA) to ensure product safety
- Perform risk assessments for the regulatory submissions
- Participate in process improvement initiatives as necessary, performing gap analysis and risk communication
- May work on special projects as needed in regard to Design Controls
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
- ISO 15189, CAP/CLIA and GCP/GCLP preferred
- Adaptable to fast-paced, dynamic work environment with shifting demands
- Experience working with eQMS
- Experience in supporting regulatory inspections