Quality Engineer (Ophthalmic Medical Device Manufacturing)

Quality Engineer (Ophthalmic Medical Device Manufacturing) sought by Benz Research & Development for the Sarasota location. Candidate must have a Bach's in Engg or Biomedical Engg & 2 yrs of exp in providing quality & validation support to the R&D of medical device mfg processes & products. Exp must incl: Utilizing chromatography data system (CDS) s/ware packages to validate & characterize sustainable biotechnology products; Managing CAPA workflows, quality event investigations, & eqpmt evaluation reviews using EtQ OR TrackWise quality mgmt s/ware systems; Creating Triennial Periodic Review validation reports, incorporating CAPA, change control, deviation history, calibration, & maintenance records; Ensuring compliance to medical device industry regulations, incl FDA 21 CFR Part 820 &/or ISO 13485; & Dsgng & executing IQ, OQ, & PQ validation protocols, ensuring eqpmt & s/ware systems meet internal quality standards & industry regulatory reqmts. 10% int'l travel reqd to conduct hands-on audits of products & processes. Respond to: send resume to Attn: HR Dept., 6447 Parkland Dr, Sarasota, FL 34243 or apply online at https://www.bvimedical.com/us/careers/