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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.
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:
4% retirement contribution match
10 days paid vacation in your first year
8 paid Holidays
Flexible work schedule
The Quality System Manager will report to the Chief Executive Officer (CEO).
Bachelor’s degree (BA/BS) from a four-year college, university, or Trade School; at least three years related experience and/or training; or equivalent combination of education and experience in the medical device industry.
Hands-on experience with FDA 21 CFR 820, Quality System Regulation (QSR) requirements; experience with FDA’s 510(k) submission process is a plus.
Excellent written and verbal communications skills
Works well independently and in a team environment
Strong organizational skills and attention to detail
Experience with Microsoft Office
Basic knowledge of software development and deployment
Telecommuting is allowed.
Internal Number: 001
AlertWatch, Inc. develops and markets patient monitoring software focused on improving the quality and safety of patient care. The solutions integrate hundreds of data elements from medical devices, EHRs and other sources, and assist clinicians in a broad set of in-patient settings. Our intraoperative software, AlertWatch:OR, has been used in over 1,000,000 surgeries. Our Labor and Delivery software, AlertWatch:OB, focused on maternal safety, has assisted with over 20,000 births. Several large studies on both solutions have shown that our software reduces major medical complications.