Galvanize · 6 hours ago
Quality System Engineer
Redwood City, CA
Full-time
Onsite
Entry, Mid Level
2+ years expGalvanize Therapeutics is a biomedical platform company focused on delivering innovative healthcare solutions. The Quality Systems Engineer will manage the Nonconforming Material Report process and develop new processes for the Quality Management System while supporting cross-functional teams with investigations and risk assessments.
Medical DeviceBiotechnologyHealthcareHealth CareMedicalTherapeutics
Responsibilities
Oversee the NMR process; lead Material Review Board meetings
Create and maintain NMR metrics
Lead the implementation of new QMS processes to support commercial activities
Perform process validations and/or QMS software validations
Perform root cause investigations and risk assessments for product and/or process failures
Lead QMS-related process improvement projects
Support QMS audits and inspections
Support Management Reviews
Support, lead, and implement QMS-related process improvement projects; write associated Quality Plans and project completion reports
Support the external standards management process
Assist with receiving inspection and product release processes
Other QMS related tasks assigned by Quality and Regulatory management
Qualification
Required
B.S. in Engineering or equivalent
2-5 years of experience working within a Quality Management System or Quality Assurance
General understanding of ISO 13485:2016 and 21 CFR Part 820
Ability to work independently in a diverse and dynamic environment
Experience with Project Management
Company
Galvanize
Galvanize Therapeutics is developing therapies to deliver life-changing healthcare solutions to patients and their doctors at the convergence of biology, engineering, and care delivery.
51-200 employees
H1B Sponsorship
Galvanize 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
2023 (3)
2022 (1)
Funding
Current Stage
Growth StageTotal Funding
$248.51MKey Investors
Sofinnova PartnersFidelity
2025-09-03Series C· $100M
2022-09-15Series B· $100M
2022-03-22Debt Financing· $4M
Leadership Team
Jonathan Waldstreicher
Founder, President & Chief Strategy Officer
Recent News
2025-11-24
Company data provided by crunchbase