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it positions - Iselin, United States - INTELLECTT INC
Description
IT POSITIONS - Intellectt, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the US:
Validation Engineers Mng spec, qualification & valdtn rqmts.
Write & execute engg chng orders rltd to Corrective & Preventive Actions (CAPAs), chng in Critical to Qlty (CTQs), release of aging reports, updates to dsgn history files.
Cndct Risk based verification for GxP (GMP, GCP, and GLP) sys & lab equipment. Create, & update Failure Mode & Effect Analysis (DFMEA) for new implants & instruments. Dsgn, dvlp & oversee valdtn components & work on inspection plans & Inspection Feature Assessment.Skills req'd:
Auto Cad, Matlab, Kaizen, Minitab, Tally, Catia, Python, Ansys & Gap Analysis.
Master's in Mech Engg, Indus Engg, Biotech Engg or any rltd fld w/1 yr exp in job off'd or rltd occup is req'd.
REGULATORY AFFAIRS SPECIALISTS:
Gather & anlyz info for prod codes, device description, FDA listing numbers & GMDN codes. Dsgn, dvlp, test, doc & support of cGxP systems asper 21CFR Part11 & US FDA.
Responsible for qualification & valdtn (IQ/OQ/PQ), master plans, protocols, changes requests, gap & RCA, risk mgmt plans, traceability matrix, summary rprts for facilities, equipment, sys & processes.
Prepare, review, authorize & submission of doc for qlty compliance & regulatory authorities.Skills req'd:
EU MDR, ISO 13485, cGmp, IQ/OQ/PQ, MDSAP, 93/42 EEC and eCTD.
Master's in chem, Reg Affiars, Bio, Health Sci or any rltd Fld w/1 yr exp in job off'd or rltd occup is req'd.
For Both Jobs:
Mail resume:
HR, Intellectt, Inc, 517 Rte 1 S, Ste 1115, Iselin, NJ
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