Our client is seeking a Quality Lead for a 4+ month contract. This individual will be an Interim Quality Lead with a strong Manufacturing and R&D background. The client is moving from a smaller production site to a larger manufacturing facility. The product is focused around Tissue and associated processes. The product passed a 510k extra cellular matrix, Xenograft. Anyone who has experience processing cow, pig or human tissue would be beneficial in this role. They have FDA approval and have started to release product. This individual will be responsible for executing the process for their internal manufacturing. The process and equipment are validated, along with the sterilization for shipping.
- Must have a strong quality background and some experience with tissue or bone Must have Quality/Manufacturing experience with tissue as a device. Medical Device experience with human tissue or Xenograft or Allograft tissue or ECM processing with Bone or tissue.
- Experience as a qualified individual to sign off on Quality items. Background working on batch release from Quality/Regulatory (letter to file), but majority is Quality focused. Have been a qualified individual for audits at prior companies, along with leading internal/external audits. BS required with advanced degree preferred.
Hybrid – Florida: Quality Lead – Tissue (231404)