Multiple Positions

RevereIT, LLC - Jobs located in Sterling, VA & var unanticpt locs t/o U.S. Sr. Validation Engineer. Prep & excute validation protocols for new & modfd systs such as equipt & s/ware. Study prdct chrcteristcs & cust reqs & confer w/ mngmnt to determ validation objs & stndrds. Create, populate, & maint d/bases for tracking validation actvities, test reslts, & validated syts. ID deviations & defects from estblshd prdct & prcess stndrds & prvde recs for reslvng deviations. Prep, maint, & rev validation & cmpliance doc i.e engng chnge notices, schmatcs, protocols, & sum rprts. Trav/relo to var unanticpt locs t/o U.S. for l/t & s/t asigns at client sites. Reqs Master's or frgn equivt in Mechl Engng, Chem Engng, Biomed, Biotech, Bioeng, or rel. Job 21REV04; Sr. Embedded Software Enginee r (Medical Device). Dsgn, devel, mod, & anlyz embdded s/ware verif plans, protocols, & rprts of med dvcs. Rev & exec test protocols & author rprts to dscribe prgrm eval, tsting, crrection, & other rel dsgn revs. Wrk w/ prdct dvlopmnt team to evale embdded syst interfaces, op reqs, & perf reqs, & build, valdte, & test auto sols. Coord w/ inter-depts to ens all doc, tsting, & reqs are in alliance to dsgn & equip specs & in compliance w/ op safety stndrds. Mon & maint defects using defect trcking systs & retest to ens they are fixed by devels. ID risks & provide risk-based tsting on embdded systs to ens they are wrkng in accord to user needs & regry compl. Trav/relo to var unanticpt locs t/o U.S. for l/t & s/t asigns at client sites. Reqs Master's or frgn equivt in Elect Engng, Electronics, Info Tech, Info Systs, Comp Sci, Phys Sci, or rel. Job 21REV03; Sr. Quality Engineer (Design Engineering). Cndct forml tech dsgn revs t/o phases of prdct devel procs. Spprt & apprv dsgn verif & valid'tn actvities. Spprt & enhance risk mngmnt actvities incl plnning, dsgn & clinicl risk mngmnt, prdction risk mngmnt, & risk summary rptg. Prov svc in areas of qual sys incl, but not lmitd to CAPA, cmplaints, post-mkt srveillnce, non-cnfrming materials, risk mngmnt, & audit spprt functs. Invstigte & t/shoot as per regs to ens cmpliance. Prep vlidtion prtocls for new or mod mnfg prcsses, systs, or equipt i.e. install, op, & perf quals. Prep dtaild rpts or dsgn statemnts based on rslts of validation. Init, mng, & close non-cnfrming mat rpts (NCMR) & dispose &/or quarntne material approp as per SOPs. Trav/relo to var unanticpt locs t/o U.S. for l/t & s/t asigns at client sites. Req Master's or frgn eqvlnt in Mech Engng, Chem Engng, Ind Engng, or rel. Job 21REV02; Sr. Validation Analyst I (Regulatory Affairs) . Anlyz reqs for var equipt or systs in compl w/ Fed Rules & Regs rel to var pharma &/or med dvc mnfng faclities. Coord, prep, or rev docs rel to reg sbmssions for var dom &/or intnat'l prjcts. Write or update stndrd op prcdures, wrk instructns, or polcies. Prep & rev prtocls & ID gaps perf Root Cause Analysis. Track defcts using Defect Mngmnt Tool & create devtion smmry rpt. Prov tech rev of data or rprts that will be incrptd into FDA submssions to assure scientfc rigor, accuracy, & clarity of prsntation. Maint or coord crrnt knowl base of existng & emrgng regs, reg stndrds, or guid docs. Prep & assst in dvlpmnt & rev of Validtn Prtocls. Compile & maint reg doc d/bases or systs. Prticpte in intl or extrnl audits. Trav/relo to var unanticpt locs t/o U.S. for l/t & s/t asigns at client sites.. Reqs Master's or frgn equivt in Reg Affrs, Pharma Sci, Pharma, & Bio, or a rel life sci disp. Job 21REV01 To apply email resume w/cover letter: jobs@revereit.com, indicate Job code. EOE