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Equipment QC Eng

Id: AT0012


  • Equipment QC Eng:       

    Draft and design layout of equipment, materials using Solidworks, AutoCAD, Minitab, and The MathWorks. Design strategies to evaluate precision and accuracy of analytical equipment, tests & measurements and production equipment using Laboratory information management system (LIMS).  Research, study, compile and prepare material on quality control activities, processes and procedures. Design and implement best quality practices and processes for new products/concepts/designs. Design forms and instructions for evaluating, assessing, reporting and documenting on quality standards in products or services. Perform System Risk Assessment to assess the risk of failure of manufacturing systems and analyze the impact on Business process in accordance with FDA regulations. Prepare and execute Installation, Operational, and Performance Qualification (IQ, OQ and PQ) protocols, and prepare a Final Validation Report. Review the Batch records for API, Bulk, Commercial finished products for further processing or commercial distribution. Work collaboratively on change controls for process, specifications for device and combination products within the Quality Management Dept. and other functions within the organization to assure manufacturing Compliance.  Write and/or review various documents for the Global Product Quality such as Protocols, Reports, SOPs, Medical Device Premarket Applications, Product Annual Reports, Design Control Documents, Risk Management, User’s Guides, Instruction Manuals, Corrective Action Preventative Actions (CAPAs), Deviations, Specifications and Change Controls. Travel to various unanticipated locations in the United States to train end users for short or long term assignments 

    Salary:                                $84,885/year

    Work Schedule:                   8:30 am-5:30pm; 40 Hrs/week (M-F)

    Requirements:                  BS or foreign equivalent in Manufacturing Engg, Mechanical Engg, Industrial Engg or related + 2 yrs of experience as Quality Engineer, Mechanical Design Engineer, Product Engineer or related, using Laboratory information management system (LIMS), Minitab, The MathWorks, MATLAB, AutoCAD, and SolidWorks.

    Job Location:                    101 College Road East, Suite 301, Princeton, NJ 08540 

    Contact:                   Moushmi Saha, HR Manager

                                      Aplomb Technologies, Inc


                                      101 College Road East, Suite 301

                                      Princeton, NJ 08540