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RA/QA Associate

Wesper

Wesper

Quality Assurance
New York, NY, USA · Remote · New York, NY, USA
Posted on Sunday, April 14, 2024
Role Description

We're looking for a smart and driven individual to help build and maintain our core quality and regulatory management framework. The right candidate will get a unique opportunity to gain first-hand experience with the medical device pathway, by working closely with design, operations and marketing teams to own and maintain key processes, facilitate and coordinate major regulatory efforts, and assist with project documentation handling and maintenance.

Reports into VP R&D.

This is a remote role with occasional travel to NYC, approximately 1x per year.

About Wesper

Mission driven startup aiming to make accurate sleep testing more convenient, affordable, and accessible.

Sleep disorders are a hidden epidemic which reduces quality and length of life for more than 10% of the population. The difficulty in diagnosing and monitoring sleep conditions is a major obstacle to the health of 100Ms of people worldwide.

Wesper is transforming the sleep industry by shrinking an entire sleep lab to a single wearable patch, helping millions live better, longer lives. Our platform delivers consumer comfort with clinical performance by using cutting-edge sensor design, a cloud-native suite of state-of-the-art algorithms and a sleek mobile app, creating a seamless experience for both patient and doctor.

Responsibilities

  • Work across all major company functions to facilitate core ISO13485-compliant processes, including key document generation and maintenance, group effort coordination and assistance with project management
  • Work with Quality Manager and Regulatory SME to ensure compliance with ISO13485 and regulatory directives
  • Assist as necessary in other project management and administrative activities

Required Skills And Qualifications

  • Highly organized and detail-oriented
  • Exceptional written and verbal communication skills
  • Agile learner capable of synthesizing new information quickly and efficiently
  • Proven track record of involvement in project management or similar process-heavy efforts

BONUS ITEMS

  • Experience working in regulated environments
  • Technical or medical background

OUR TEAM - Built for Good

We pride ourselves on transparent communication— open discussion is critical to our performance and is how we continue to grow. We focus on accountability, humility, and constant learning. We believe in finding a better way through the use of data and attention to detail. We work towards making sleep medicine easy and we do it for our users.

Compensation & Benefits

This role has a base salary of $65,000 - $75,000 The range displayed reflects the minimum and maximum target for new hire salaries for the position. Individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

  • Competitive salary
  • Global team
  • Friendly, nerdy coworkers
  • Daily stand-ups and open door policy
  • Encouragement to pursue initiatives
  • Flexible paid time off
  • Casual dress
  • Support for personal development
  • Referral bonuses

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