Quality Engineer

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

Benefits offered by this job

Medical, dental, vision coverage

Life insurance

Disability protection (short & long)

401(k) & flexible PTO

Job summary

Galvanize Therapeutics, a biomedical platform company, seeks a Quality Engineer in Redwood City, CA to support design output evaluation for quality requirements and maintain the Quality Management System.

Requirements include a B.S. in Mechanical Engineering and 2–5 years in a Medical Device QMS, with manufacturing experience and ISO 13485/21 CFR 820/ISO 14971 familiarity. Travel up to 25% and Mandarin proficiency are optional assets.

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%).
• 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 and Fault Tree Analysis for ISO 14971.
• Drive risk mitigation through design and product requirement definitions.
• Support receiving inspection, inventory, purchasing, and other activities if requested.
• Support qualification of suppliers in Galvanize's QMS, including supplier evaluations and documentation.
• Support Software Verification/Validation activities related to R&D, sustaining engineering, and QMS.

Skills

QMS experience in medical devices

Manufacturing environment

Procedures, reports writing

Independent work in dynamic setting

ISO 13485, 21 CFR 820, ISO 14971

Travel up to 25% for supplier audits

Mandarin proficiency (preferred)

Education

B.S. in Mechanical Engineering

Job description

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 with fair chance laws.