Life Sciences & Technology
| Quality Assurance & Quality Control
A BDN client is working on a combination product, and they would like to bring on an additional resource to help on the Medical Device side. The consultant would be responsible for overseeing the client’s Tier 1 supplier audit program, which will entail being the point of contact and scheduling the audits in addition to performing them. They anticipate there being 3-4 audits required initially, but this will most likely increase. The client has requested that the consultant be well-versed in ISO 13485:2016, ISO 11135, and CFR 820. He/she must have Combination product quality systems experience. The client is a virtual company with no onsite production and managed all by a 3rd party. Prior experience around this would also be highly preferred. The client may request to have the consultant come onsite for occasional meetings.