Quality Engineer

Galvanize; Redwood City (CA); On-site; USD 115,000 - 130,000; Full time

Benefits offered by this job

Health benefits

Life insurance

401(k) & PTO

Job summary

Galvanize Therapeutics, based in Redwood City, CA, seeks a Quality Engineer to support the Quality Management System, CAPA reviews, supplier audits, and compliance with ISO 13485, 21 CFR Part 820, and ISO 14971. The role involves new product development support, risk management, and QMS enhancements, with travel about 25% to supplier sites.

Applicants should have a B.S. in Mechanical Engineering or related field and 2–5 years in medical device quality, plus strong documentation and

Qualifications

• 2-5 years of work experience within a Medical Device Quality Management System.
• Experience working in a Manufacturing Environment.
• Proficient in writing procedures, reports, and presentations.
• Ability to work independently in a diverse and dynamic environment.
• General experience with medical devices, specifically capital equipment and disposables.
• General understanding of ISO 13485, 21 CFR Part 820, and ISO 14971.
• Ability to travel (approximately 25%) to support supplier audits.
• Proficiency in Mandarin preferred (speaking, reading, and writing).

Responsibilities

• Responsible for new product development activities.
• Support the development and deployment of the quality system that meets company objectives.
• Review and update CAPAs and complaints as needed.
• Supplier documentation and completion of Verification and Validation activities including traceability to requirements in compliance with applicable quality system regulations
• Responsible for change order implementation activities.
• Review and challenge NPD engineering related activities and documentation that includes protocols and test reports.
• Facilitate the documentation of risk management using industry standard tools including FMEAs, Fault Tree Analysis for systems, and other workflows to ISO 14971.
• Drive risk mitigation, including verification of risk mitigations, through design and product requirement definitions.
• Support receiving inspection, inventory, purchasing, and other activities if requested to do so.
• Support qualification of suppliers in Galvanize’s QMS, inclusive of performing supplier evaluations and working with suppliers to obtain necessary documentation for their qualification in the QMS.
• Support Software Verification/Validation activities related to R&D, sustaining engineering, and QMS.

Skills

Medical device QMS experience

Manufacturing environment

Technical writing

Independent work

Medical devices knowledge

Quality standards ISO 13485/820/14971

Travel to supplier audits

Mandarin preferred

Education

B.S. in Mechanical Engineering

Job description

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.

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.

The Quality Engineer is responsible for supporting the evaluation of design outputs for quality requirements. This person is responsible for establishing and/or maintaining quality, risk, or other management plans for equipment and processes for general and specific product performance needs. This person is also responsible for supporting the continued maintenance and growth of the Quality Management System.

This position is based in Redwood City, CA. Applicants that do not currently reside in the San Francisco Bay Area will not be considered. Relocation is not being offered for this position.

Education And Training

B.S. in Mechanical Engineering or other engineering discipline

Skills And Experience

• 2-5 years of work experience within a Medical Device Quality Management System
• Experience working in a Manufacturing Environment
• Proficient in writing procedures, reports, and presentations
• Ability to work independently in a diverse and dynamic environment
• General experience with medical devices, specifically capital equipment and disposables
• General understanding of ISO 13485, 21 CFR Part 820, and ISO 14971
• Ability to travel (approximately 25%) to support supplier audits
• Proficiency in Mandarin preferred (speaking, reading, and writing)

Key Responsibilities

• Responsible for new product development activities.
• Support the development and deployment of the quality system that meets company objectives.
• Review and update CAPAs and complaints as needed.
• Supplier documentation and completion of Verification and Validation activities including traceability to requirements in compliance with applicable quality system regulations
• Responsible for change order implementation activities.
• Review and challenge NPD engineering related activities and documentation that includes protocols and test reports.
• Facilitate the documentation of risk management using industry standard tools including FMEAs, Fault Tree Analysis for systems, and other workflows to ISO 14971.
• Drive risk mitigation, including verification of risk mitigations, through design and product requirement definitions.
• Support receiving inspection, inventory, purchasing, and other activities if requested to do so.
• Support qualification of suppliers in Galvanize’s QMS, inclusive of performing supplier evaluations and working with suppliers to obtain necessary documentation for their qualification in the QMS.
• Support Software Verification/Validation activities related to R&D, sustaining engineering, and QMS.

This role pays between $115,000 and $130,000 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 to fair chance laws.