Vice President of Manufacturing and Supply Chain
COHERO HEALTH INC.
NEW YORK, NY, Report to President/CEO, a respiratory hardware and mobile application, Class II medical device start-up, with less than 10 employees, a remote position responsible for establishing supply chain strategy, sourcing contract manufacturing, supplier management, quality systems, customer service and distribution.
- Sourced contract manufacturers in Asia and Europe.
- Implemented the QMS compliant with FDA 21CFR 820 and ISO 13485.
- Audited contract manufacturers to ISO 13485 and negotiated supply agreements.
- Coordinated design verification and validation testing to support FDA 510(k) submissions.
- Established customer service and distribution with 3PL.
- Scaled manufacturing capacity to supply US commercial launch.