Sr. Quality Engineer

Eargo

San Jose, CA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 06/03/2021
  • Website: eargo.com
  • Company Address: 1600 Technology Drive, 6th Floor, San Jose, CA 95110

About Eargo

We’re Eargo. A company made up of ENT surgeons, tech geeks and dreamers, united in our belief that people should be able to hear life to the fullest. Because the world is full of great things to hear. And because, well, we really like people.

Job Description

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 44 million Americans currently experience hearing loss and 73% 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 Senior Quality Engineer is responsible for both support of the internal Quality Systems maintenance and Quality Engineering oversight at the contract manufacturer. This includes playing a key role in the manufacturing transfer of new products from product development to contract manufacturers. In addition to the 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 the day-to-day oversight of the CM from a
    • Quality engineering,
    • Process compliance and
    • Quality system compliance
    • Ensure accurate and compliant deployment of changes (ECOs)
    • Make sure all aspects of an ECO are appropriately executed at the CM
    • Product disposition, Training and Certification, Document Control on the line, etc.
    • Perform "First Article" inspection of the product to ensure implemented changes are in effect and the process is repeatable
    • Assist Eargo ME with training and certification activities
    • Be the technical "canary in the coal mine" for Eargo to provide the organization leading indicators of issues in production
    • Coordinate the determination of root cause and corrective actions and develop project plans to drive change.
    • Report monthly progress metrics.
    • Participate as a member of the internal audit team.
    • Conduct internal audits, assign and drive corrective action tasks to completion, and perform verification and effectiveness reviews as required.
    • Participate as a member of the supplier audit team.
    • Support the return device analysis and assist in reporting the RMA analysis to senior management.
    • Generate, manage and drive to closure SCARs opened for CMs
    • Manage critical quality system related functions internally at Eargo as we scale:
    • Complaint management and trending
    • CAPA management
    • CATF management
    • SCAR management
    • NCMR management
    • Internal Audit logistics and execution

THE QUALIFICIATIONS

    • BS in Electrical Engineering, Mechanical Engineering or related engineering fields
    • 5 years of experience in medical device quality engineering or other equivalent regulated environments
    • Demonstrated experience in technical project/program leadership and process management
    • Demonstrated ability to communicate and work collaboratively across functions, such as engineering, development, and other support groups
    • Experience across all product lifecycle phasesLean and/or Six Sigma experience a plus
Eargo is an Equal Opportunity Employer committed to hiring a diverse workforce. 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. We offer a competitive compensation and benefits package including stock options.

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.