Staff Design Quality Engineer
Caris Life Sciences
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $120,000 - $138,000 per year
Job Level
About the role
- 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.
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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Design ControlsDesign history file (DHF)Risk ManagementVerification and Validation (V&V)pFMEAISO 13485FDA QSR/21 CFR Part 820ISO 14971IVDRData analysis tools
Soft Skills
CollaborationLeadershipCommunicationProblem-solvingOrganizational skills