Quality Systems Engineer

Galvanize • Redwood City, CA

9d • $105,000 - $115,000 • Onsite

About The Position

The Quality Systems Engineer is responsible for managing the Nonconforming Material Report (NMR) Process. The Quality Systems Engineer is also responsible for developing and implementing new processes to fit Galvanize’s Quality Management System (QMS) needs and for supporting the continued maintenance and growth of the QMS. The Quality Systems Engineer will also assist cross-functional teams with root cause investigations and risk assessments.

Requirements

• B.S. in Engineering or equivalent
• 1-4 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

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

Benefits

• medical
• dental
• vision coverage
• life insurance
• short- and long-term disability protection
• 401(k)
• flexible paid time off

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level