QMS Contractor for SaMD Design Control Deliverables and ISO 13485 Support at Big Health | Torre
QMS Contractor for SaMD Design Control Deliverables and ISO 13485 Support
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Big Health

QMS Contractor for SaMD Design Control Deliverables and ISO 13485 Support

Big Health
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Freelance
Recurrent (~40 hours per week)
Provide your expected compensation while applying
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Remote (for United States residents)
Shared by
Gabriel Del Pino
 13 days ago

Responsibilities

We’re looking for a QMS contractor to pitch in with system support for our SaMD products.At Big Health, our mission is to help millions back to good mental health by providing fully digital, non-drug options for the most common mental health conditions, including our flagship product SleepioRx, which is FDA-cleared for the treatment of chronic insomnia in patients 18 and older.The main focus of this role is on design control deliverables, as well as supporting ISO 13485/QMSR processes such as CAPA, supplier evaluations and document control in our eQMS. Ideally, the contractor has hands on experience with design controls for SaMD, can execute against established procedures without a long ramp, and enjoys the fun, innovation, and complexity of working at a startup.Up to 40 hrs/week, remote, must be US work eligible. Pay commensurate with experience.If this sounds like you, or someone you know, please email a resume to qmsteam@bighealth.com - look forward to hearing from you!
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