{"id":3048056,"url":"https://alion.io/job/galvanize-therapeuticsr-inc-quality-engineer","title":"Quality Engineer","company":{"id":3783850,"name":"Galvanize Therapeutics® Inc","domain":"galvanizetx.com","url":"https://alion.io/company/galvanizetx","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Rippling","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Redwood City, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":115000,"max":130000,"currency":"USD","period":"year","gross":null,"usd_annual":130000},"salary_estimate":null,"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"21 CFR Part 820","optional":false},{"name":"CAPA","optional":false},{"name":"ISO 13485","optional":false},{"name":"ISO 14971","optional":false},{"name":"Verification & Validation","optional":false}],"status":"live","first_seen_at":"2026-10-21T23:44:59Z","employer_posted_date":"2026-10-21","last_verified_at":"2026-10-28T11:32:53Z","board_verified":true,"closed_at":null,"days_open":6,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":6},"description":"About Galvanize Therapeutics\nGalvanize 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.\nThe 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.\nThis 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.\nEducation and Training:\nB.S. in Mechanical Engineering or other engineering discipline\nSkills and Experience:\n2-5 years of work experience within a Medical Device Quality Management System\nExperience working in a Manufacturing Environment\nProficient in writing procedures, reports, and presentations\nAbility to work independently in a diverse and dynamic environment\nGeneral experience with medical devices, specifically capital equipment and disposables\nGeneral understanding of ISO 13485, 21 CFR Part 820, and ISO 14971\nAbility to travel (approximately 25%) to support supplier audits\nProficiency in Mandarin preferred (speaking, reading, and writing)\nKey Responsibilities\nResponsible for new product development activities.\nSupport the development and deployment of the quality system that meets company objectives.\nReview and update CAPAs and complaints as needed.\nSupplier documentation and completion of Verification and Validation activities including traceability to requirements in compliance with applicable quality system regulations\nResponsible for change order implementation activities.\nReview and challenge NPD engineering related activities and documentation that includes protocols and test reports.\nFacilitate the documentation of risk management using industry standard tools including FMEAs, Fault Tree Analysis for systems, and other workflows to ISO 14971.\nDrive risk mitigation, including verification of risk mitigations, through design and product requirement definitions.\nSupport receiving inspection, inventory, purchasing, and other activities if requested to do so.\nSupport 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.\nSupport Software Verification/Validation activities related to R&D, sustaining engineering, and QMS.\nThis role pays between $115,000 and $130,000 per year, and your actual base pay will depend on your location, skills, qualifications, and experience.\nGalvanize 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.\nGalvanize Therapeutics is an Equal Employment Opportunity Employer. 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