Jobs · Quality Assurance · New Jersey

Product Test Engineer - Req Instron Mechanical Testing & Medical Device Industry Exp

MillenniumSoft Inc · Franklin Lakes, NJ · 7 mo ago
Quality AssuranceFull-time

Position Summary

- The primary role of the Combination Product Test Engineer is the timely and accurate execution of testing as scoped within individual projects and per client requirements. - This includes but is not limited to; sample receipt, prep, storage and shipping, as well as protocol and report generation, data review and summary. - This role utilizes standard and custom laboratory equipment.

Essential Duties and Responsibilities

- Conducts timely sample intake, including receipt, proper identification, storage and return shipments as needed. - Conducts testing as assigned utilizing appropriate test methods, protocols specifications and equipment (includes product and/or equipment testing), including adhering to test schedules (e.g. stability pulls, aging pulls). - Conducts data analysis as per protocol or specifications utilizing variety of data analysis tools (e.g. excel, JMP, MiniTab). - Communicate challenges, scheduling or testing conflicts and other issues to management in timely manner. - Maintains inventory of lab supplies, including but not limited to; general supplies (e.g. PPE, wipes, cleaners…) and chemicals use for routine testing and/or cleaning. - Conducts routine sample disposition (e.g. return to client, disposal), including coordination of hazardous waste disposal. - Responsible to maintain the lab and storage areas in a clean an organized manner. Includes routine lab cleaning and housekeeping. - Adheres to ZebraSci Quality Systems, including but not limited to; timely identification, and notification of potential Quality Events (e.g. OOS, Deviations, CAPA…) and the subsequent forward processing and investigation of such events. - Follows established Standard Operating Procedures, makes recommendations for edits, enhancements, and/or new procedures. - Reviews and may draft equipment or other lab documents (e.g. SLP, LWIs) under supervision from lab management. - Reviews test results, including data analysis and draft reports. - Interacts with clients to provide updates and technical overviews as needed under supervision from lab management. - Reviews and may author test methods/protocols/reports under supervision from lab management.

Education, Experience and Skills

- Associates degree with 0-2 years’ experience. - A combination of education and experience in laboratory services, medical device, IVD and/or pharmaceutical industry, preferably in a contract testing and/or laboratory environment will be considered. - Knowledge of GLP, cGMPs, ISO and ASTM methodologies beneficial. Technical written/oral communication skills with working knowledge of Excel and other data analysis tools required. - Attention to detail with the ability to multi-task in a fast-paced environment and manage changing priorities.

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