We're Eargo and we're on a mission to disrupt and transform the hearing health industry. We're looking for those passionate individuals who jump out of bed in the morning dreaming of new ways to improve the lives of our customers. We're tech geeks and dreamers. We believe that every voice is unique and every idea is worth talking about. Moreover, we believe in passion and having fun. Because it takes passion to change the world and if you have passion in what you're doing, you naturally have fun doing it.
The RoleThe Quality Assurance Technician is responsible for device disinfection process and return device failure analysis. In addition, support QA team with inspection of finished goods from the contract manufacturer and in-house manufacturing line.
Perform device disinfection and cleaning towards reprocessing per established procedures. Maintain records of inspection. Perform testing of disinfected devices
Failure analysis of complaint units per established procedure
Final Product Release inspection process
DHR Review
Ensure all quality issues are communicated in a timely manner
Assist in initiating Non-conformance Material Report
Perform inspection of returned goods based on the established procedures. Maintain records of inspection
Assist with verification activities as needed under an engineer's direction
The Qualifications
Able to effectively communicate
Good understanding of FDA, ISO requirements for medical device development
Must be able to understand and execute on directions
Must be detail oriented, well organized and have good oral and written communication skills
Must be able to accomplish objectives with minimal supervision
Must be proficient in use of measurement tools such as micrometers, calipers, etc.
Excel skills to generate spreadsheets, performance reports for QA performance is desirable
Minimum 1-2 year experience in a medical device company
Physical Environment/working conditions - assembly line, able to lift up to 40 Ibs