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.
Over 48 million Americans currently experience hearing loss and 80% of them do nothing about it. Their denial has many different shades, but more often than not it's related to social stigma. We at Eargo exist to give people their hearing without the social stigma so that they can go on being the cool person they are. That's why we get out of bed in the morning and we take that seriously. And we're looking for some great minds to join us on our journey.
The Role
The Quality Engineer is responsible for both internal Quality Systems maintenance and Quality Engineering oversight at the contract manufacturer Organization (CMO). This includes playing a key role in the manufacturing transfer of new products from product development to contract manufacturers. In addition to release of new products, you will also manage the quality engineering activities for existing products at the contract manufacturer and will be the main point of contact for internal maintenance of quality system activities.
The Responsibilities
Be the main point of contact for day-to-day oversight of the CMO from quality engineering, process compliance and quality system compliance
FAI inspection techniques and use of CMM or other inspection equipment
Ensure accurate and compliant deployment of changes (ECOs)
Make sure all aspects of a ECO is appropriately executed at the CM
Create and review Protocols for Manufacturing support IQ/OQ/PQ
Perform "First Article" inspection of product to ensure implemented changes are in effect and the process is repeatable
Assist Eargo ME's with training and certification activities (CMO)
Be the technical go to for design efforts in development and review of Design FMEA's (Process and User FMEA's)
Strong CPK and other IQC statistical methods to be use in the organization as leading indicators of issues in production
Assist in-house reliability efforts and design builds at CMO. In addition to performing accurate trending of metrics as applicable (SPC)
Perform the return device analysis and assist in reporting the RMA analysis to senior management as needed.
Perform unannounced audit of production line at suppliers or CMO
Generate, manage and drive to closure SCARs opened for CMs
The other key responsibilities include:
Manage critical Quality System related functions internally at Eargo as we scale:
Complaint management and trending
CAPA management
SCAR management
NCMR management
THE SKILL SET
BS in Electrical Engineering, Mechanical Engineering or related Quality engineering fields
5 years of experience in medical device quality engineering or other equivalent regulated environments (AS9000, ISO, Aerospace or Pharma)
Demonstrated experience in technical project/program leadership and process management
Demonstrated ability to communicate and work collaboratively across functions, such as engineering ; R&D product groups
Experience across all product lifecycle phases
Lean and/or Six Sigma experience a plus
Eargo is an Equal Opportunity Employer. All employment is decided upon the basis of qualification, merit and business need. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.