Job Overview

AlertWatch has received clearance for several solutions, and has a quality management system in place. Now, we’re looking to grow with a Quality System Manager who can update our processes as we install at more hospitals, manage a distributed development team, and oversee a more complex development cycle. This is an excellent opportunity to be actively involved in a start-up where the ability to collaborate with our developers is paramount, and the impact on the firm will be immediate.

The Quality System Manager is responsible for activities related to the QMS but will also contribute to customer facing facets of the business. This position will be fun for candidates that want a front-seat to the post-COVID expansion of tele-health. 

We are a small, tight-knit, and scrappy team that love to build and deliver software to our clinical users, and we need a team member who can learn and grow along with us.

Primary Responsibilities

• Develop, document, implement, and maintain quality systems and processes to ensure compliance with Company, Customer, and FDA requirements.
• Oversee 510(k) submissions.
• Collaborate with all employees to ensure the delivery of a safe product that meets the needs of end users.
• Assist our software development team with modernizing our process for distributed, remote work.
• Ensure that marketing materials accurately reflect product labeling and use.
• Understand software to ensure the QMS supports a practical and manageable development process.
• Facilitate management reviews and audits.
• Gather ongoing quality metrics related to customer usage, troubleshooting, and CAPA.
• Communicate, both orally and in writing, with clinical users and business partners.
• Participate in product development and clinical requirements gathering.
• Ensure department personnel are adequately trained in the performance of their job.

Benefits & Compensation

AlertWatch offers a robust benefits package which includes:

• • Medical Coverage
  • Stock Options
  • 4% retirement contribution match
  • 10 days paid vacation in your first year
  • 8 paid Holidays
  • Flexible work schedule

Reports To

The Quality System Manager will report to the Chief Executive Officer (CEO).