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    it positions - Iselin, United States - INTELLECTT INC

    INTELLECTT INC
    INTELLECTT INC Iselin, United States

    3 weeks ago

    Intellectt Inc background
    Description
    IT POSITIONS - Intellectt, Inc - Iselin, NJ Iselin, NJ & various unanticipated locations throughout the U


    S:

    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 SPECIALIST

    S:

    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
    recblid rycg7il1fq6o23qstklnmlwiq71w3u


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