QMS (Quality Management System) Lead

Company:

Over the past five years, we've developed a non-invasive, FDA cleared wearable device to treat pain. Our clinical trials indicate that Enso is more effective than Vicodin. The device is sleek, unobtrusive and designed in a way that allows people to be active during use. The device is recommended by physicians from major health systems (Stanford, Harvard, etc), and we're a VC backed company.

People:

We are a team of entrepreneurs, engineers, and researchers, with a diverse set of skills and backgrounds. Pain is personal to us and we care deeply about helping people. We value honesty, humor and humility. We work hard towards the mission :)

Job Description & Responsibilities:

We are looking for QMS (quality management system) lead. Ideal candidate would first get him or herself familiarized with our current quality system, then assist us in design input review, output review, design verification and validation. Candidates will also conduct impact analysis and risk assessment and prepare for an FDA audit.

Ideal Candidate:

• Minimum 1+ years experience in class II medical device company
• Understanding of ISO 13485
• Conducted impact analysis and risk assessment
• Implemented CAPA