huMannity Medtec · 1 day ago
Senior Quality Engineer
Santa Clarita, CA
Full-time
Onsite
Senior Level
$130K/yr - $150K/yr
5+ years exphuMannity Medtec is seeking a Senior Quality Engineer to work closely with R&D, Manufacturing, and Quality Assurance to develop and verify Class III medical devices for clinical studies. The role involves reviewing and approving engineering documents, supporting manufacturing activities, and ensuring compliance with quality standards.
Health CareHospitalMedical
Responsibilities
Represent Quality Assurance on product development teams
Participate in design reviews and technical meetings
Review and approve Engineering Change Orders
Provide Quality Engineering input to Manufacturing teams and support manufacturing/QC activities
Assist with transfer of design to pilot production
Drive non conformances to closure through root cause analysis and CAPA
Support risk analysis, design assurance, and verification activities for Class III products
Support cleanroom and sterilization processes
Support quality system activities (CAPA, supplier quality, MRB) and their improvement
Qualification
Required
Bachelor's degree in engineering or a related field and/or a combination of 5+ years practical and educational experience in the medical device industry is required
Fluent with Excel spreadsheets
Reading engineering drawings (e.g. SolidWorks®, AutoCAD®, etc.)
Must have excellent written and verbal communication skill
Good understanding of CFR 820 and ISO 13485:2016
Methodical approach to problem solving
Self-motivated organized team player with high ethical standards
Must have a good working knowledge of CFR 820, ISO 14971 and ISO 13485
Support quality system activities (CAPA, supplier quality, MRB) and their improvement
Drive non conformances to closure through root cause analysis and CAPA
Support risk analysis, design assurance, and verification activities for Class III products
Support cleanroom and sterilization processes
Provide Quality Engineering input to Manufacturing teams and support manufacturing/QC activities
Assist with transfer of design to pilot production
Review and approve Engineering Change Orders
Participate in design reviews and technical meetings
Represent Quality Assurance on product development teams
Preferred
EE or ME preferred
Benefits
9/80 work week
Company
huMannity Medtec
huMannity Medtec provides medical conditions.
51-200 employees
H1B Sponsorship
huMannity Medtec has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (2)
2024 (1)
2022 (3)
2021 (1)
Funding
Current Stage
Growth StageLeadership Team
Anthony Ng
Director of Electrical Engineering
Company data provided by crunchbase