This small, well funded Ultrasound Imaging company in Issaquah, WA is building their local team. The site will include equipment repair for the Americas, including Middle and South America, product production and building out manufacturing efforts, and early stage innovation with a tiger team of ultrasound and traducer engineers developing innovation in the imaging industry. They need a well rounded Quality Engineer to ensure their QMS aligns with their other sites and manage compliance as they build out all of these capabilities.

Job responsibilities:

1\. Ensuring that quality system requirements are effectively established and effectively maintained in accordance;

2\. Reporting on the performance of the quality system to management with executive responsibility for review;

3\. Responsible for organizing and conducting internal audits and management reviews of the company's quality management system;

4\. Production Quality experience, QMS experience and interest in or experience in Design Quality.

Requirements:

Bachelor's degree or above in medical device-related majors

3 + years of experience in active medical device quality management or production and technical management, and be familiar with medical device regulatory regulations and standards;

Be familiar with the technical characteristics and quality control requirements of medical ultrasound diagnostic equipment;

Have a training certificate with the currently valid versions of ISO 13485 and ISO 14971

On site in Issaquah, full-time, US citizen or Green Card