Quality Systems Engineer
About the role
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.
Qualifications
Education and Training: B.S. in Engineering or equivalent
Skills and Experience:
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
What you'll do
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
Pay
This position pays between $105,000 and $115,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience.
Benefits
Galvanize offers a robust benefits package to full-time employees, including medical, dental, and vision coverage, life insurance, short- and long-term disability protection, 401(k), and flexible paid time off.
About Galvanize Therapeutics
Galvanize is a biomedical platform company operating at the convergence of engineering, biology, and healthcare delivery, aiming to deliver life-changing solutions to patients and their doctors. We design and develop Pulsed Electric Field Systems to achieve meaningful and lasting therapeutic outcomes for patients.