Quality Systems Engineer

Quality Systems Engineer

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.

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.

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

This position is based at the Galvanize Therapeutics office in Redwood City, CA and requires you to be in the office. This is not a remote position.

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

This role pays between $105,000 and $115,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience.

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.

Galvanize Therapeutics is an Equal Employment Opportunity Employer. We provide equal employment opportunities to all qualified applicants and employees, and prohibit discrimination and harassment of any type, without regard to race, sex, pregnancy, sexual orientation, gender identity, national origin, color, age, religion, protected veteran or disability status, genetic information or any other status protected under federal, state, or local applicable laws.

We will consider for employment qualified applicants with arrest and conviction records in accordance with fair chance laws.