Document Control Specialist

Eargo

San Jose, CA, US
  • Job Type: Full-Time
  • Function: Legal
  • Post Date: 04/03/2021
  • 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 ROLE
 
The RAQA Associate is responsible for daily management of change orders, training, and complaint report-ability decisions. The RAQA Associate can communicate effectively and assist cross-functional team members in quality related functions. The RAQA Associate supports activities to help Eargo maintain compliance with applicable regulations and standards.

THE RESPONSIBILITIES

    • Lead change control activities in the change management system.  
    • Provide final quality review (QC Check) for all documents going through the change control process. 
    • Maintain employee and consultant quality system training records (internal and external) and tracking system.
    • Ensure employees and consultants notification of required quality system training. 
    • Evaluate each customer complaint and event report for additional reporting requirements to the appropriate regulatory authorities (IRB, MDR, cMDR). 
    • Purchase requested external standards and act as the liaison with the supplier providing standards support.   Maintain library of the purchased external standards and organize filing of such standards. 
    • Compile and analyze QS data that will help assess QS effectiveness. 
    • Provide support for RAQA activities for quality system management as required.

THE QUALIFICATIONS

    • Minimum 2+ years professional experience in similar role.
    • Must be proficient with MS Word, Excel and Adobe Acrobat.  Experience with database management is a plus.
    • Good oral and written communication skills. Ability to communicate with various organizational functions and levels.
    • Must be well-organized with an eye for detail and accuracy.
    • Receives periodic direct supervision but conducts daily/routine activities independently.
    • Good understanding of FDA, ISO requirements for medical device development is preferred.
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.