Quality Engineer

Galvanize•Redwood City, CA

7d•$115,000 - $130,000

About The Position

The Quality Engineer supports the evaluation of design outputs for quality requirements and establishes and/or maintains quality, risk, and other management plans for equipment and processes to meet general and specific product performance needs. The role also supports the continued maintenance and growth of the Quality Management System. This position is based in Redwood City, California. Applicants who do not currently reside in the San Francisco Bay Area will not be considered, and relocation is not offered. The role pays $115,000 to $130,000 per year; actual base pay depends on location, skills, qualifications, and experience. Galvanize offers full-time employees medical, dental, and vision coverage, life insurance, short- and long-term disability protection, a 401(k), and flexible paid time off.

Requirements

B.S. in Mechanical Engineering or another engineering discipline.
2–5 years of work experience within a Medical Device Quality Management System.
Experience working in a manufacturing environment.
Proficiency 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.

Nice To Haves

Proficiency in Mandarin, including speaking, reading, and writing.

Responsibilities

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