We are a dynamic group of professionals providing regulatory, quality and clinical services for the medical device industry. Our team supports start-ups, mid-sized private companies and large corporations at all stages of the product life cycle. We work across a broad spectrum of technologies and treatment modalities; our clients develop both next generation and paradigm shifting devices. Our product exposure includes implants, single use disposables, instruments (manual, laser, robotic, etc.), capital equipment, combination products, software as a medical device (SaMD), medical apps, in vitro diagnostics and more.
We are seeking a Software Quality Engineer to support our senior Quality team. The Software Quality Engineer will organize and manage the Quality activities for clients to help identify and meet Quality Management System (QMS) needs. Additionally, the Software Quality Engineer will evaluate Design Outputs and Design Changes for quality requirements, work with clients to assure quality, risk, or other management plans for equipment and processes for general and specific product performance needs are established according to the client’s QMS. These activities must be in accordance with industry standards and testing including as applicable, FDA Quality System Regulation, ISO 13485, ISO 14971, ISO 62304, ISO 82304 and the EU Medical Devices Regulation.
This position requires that you work in our San Jose office.
MAJOR DUTIES OF POSITION:
KNOWLEDGE AND SKILL REQUIREMENTS:
The above description is intended to describe the general content, identify the essential functions of, and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or requirements.
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