Manufacturing - Quality
This is a full time position working at the Roam facility in San Francisco. You will join our manufacturing team to build the next generation of systems and prepare our quality system for commercial manufacture as we develop FDA regulated products. Some of the specific responsibilities include:
Lead Quality to create and implement a QMS (Quality Management System) for medical device, starting with FDA: 21 CFR 820
Potential candidate will generate and implement quality control SOP’s, FMEA’s, IQ, OP, PQ, internal and external audits, etc.
Implement lean quality system in preparation for mass manufacture based on feedback from external vendors while in collaboration with internal manufacturing and design teams
Develop and maintain product verification and testing documentation that is consistent with Quality System Regulations and compliant with FDA 21 CFR 820, ISO 90001 and ISO 13485 standards
Participate in device manufacture as required to meet company production schedule
We are seeking highly motivated and adaptable individuals who will explore the peaks and valleys of all problems that may come up while building a new generation of robots for everyday life.
BS in Mechanical or Manufacturing Engineering or equivalent field
3+ years demonstrated experience transitioning design prototypes to manufacturable products in Quality
Grasp of manufacturing best practices for high volume manufacturing techniques such as injection molding
Familiar with Agile, Visual Vault, Enzyme, or other Quality Management Systems
Direct experience with 21 CFR 820. Experience with ISO 13485 preferred
A track record of effective application of design control best practices to product development
Excellent verbal and written communication. Highly organized with a strong attention to detail
Familiarity with starting a Quality Management System
Able to deliver quality work in a fast-paced startup environment
Ability to relocate to work at the Roam San Francisco office
Experience completing DFM efforts on robotic systems or other electro-mechanical hardware
Experience transitioning a single design from initial design prototypes to injection moldable parts
Strong preference given to candidates available immediately
US Citizen or permanent resident
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, gender, sexual orientation, age, marital status, veteran status, or disability status.