Quality Systems Engineer
Job Description
Job DescriptionSalary: $110,000 to $130,000
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 Corrective and Preventive Action (CAPA) Process. The Quality Systems Engineer is also responsible for developing and implementing new processes to fit Galvanizes 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.
Key Responsibilities
- Oversee the CAPA process; lead CAPA Board meetings
- 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
- Other QMS related tasks assigned by Quality and Regulatory management
Key Requirements
Education and Training: B.S. in Engineering or equivalent
Skills and Experience:
- Experience working within a Quality Management System or Quality Assurance
- General understanding of ISO 13485:2015 and 21 CFR Part 820
- Ability to work independently in a diverse and dynamic environment
- Experience with Project Management
At Galvanize Therapeutics, your base pay is one part of your total compensation package. This role pays between $110,000 and $130,000 per year, and your actual base pay will depend on your skills, qualifications, experience, and location.
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.