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Quality Assurance Specialist

We’re Eargo and we’re on a mission to disrupt and transform the hearing health industry! We’re looking for 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. But, we do have a serious side. Over 48 million Americans currently experience hearing loss and 80% of them do nothing about it. More often than not it’s related to social stigma. This is why we 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.

Does this sound like a place you want to work? Well, you’re in luck! We’re looking for some great minds to join us on our journey.

We are seeking a team oriented, driven and self-starter specialist to join the RAQA Team. The Quality Assurance Specialist will be responsible for the maintenance of the quality subsystems. Able to effectively communicate and assist cross-functional team members in quality related functions. Has an understanding of the document control process.

 

This is what you’ll be doing:

  • Ensure all quality actions are communicated in a timely manner
  • Assist in initiating Non-conformance Material Report
  • Ensure timely closure of internal audit findings to ensure compliance with all quality standards.
  • Ensure timely closure of the CAPAs
  • Maintenance of Tool and equipment calibration
  • Ensure the completeness of required paperwork for supplier approval and maintenance of the supplier certifications
  • Document control management and ensure timely closure of ECOs
  • Assist in making improvements/ flowcharts to simplify understanding of SOPs and Work instructions
  • Maintenance of the employee training program

 

This is what we’re looking for:

Must-have’s

  • Must have minimum 3-5 years’ experience in medical device design and manufacturing environment
  • Able to effectively communicate and assist cross-functional team members in quality related functions.
  • Must have practical and working knowledge of ISO 13485, 21 CFR 820
  • Good understanding of FDA, ISO requirements for medical device development
  • Receives periodic direct supervision but conducts daily/routine activities independently
  • Contact supplier quality departments to ensure closure of paperwork and updated ISO certifications
  • Must be detail orientated, well organized and have good oral and written communication skills
  • Excel skills to generate spreadsheets, performance reports for QA performance
  • Proficient in Microsoft Office
  • Must have undergraduate degree

Nice-to-have’s

  • Experience in leading presentations or trainings
  • Self-starter who is capable of taking innovative initiatives
  • Experience with startup companies
  • Experience with Omnify, or the equivalent in other PML systems
  • Experience with Salesforce system

 

Does this sound like you? 

If so, let’s talk.

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