Job Description
Job Purpose
This position is a member of the Incoming Receiving Inspection team. The position is responsible for perform testing and inspection activities for raw material, components and OEMs, with accurate results in a timely manner.
Job Functions:
*Perform destructive and non-destructive testing on raw materials/components using Micrometers, Dial Calipers, Pin Gauges, Height Gauges, Thread Gauges, Optical Comparator, Micro Vu and other Precision Measuring Instruments.
*Reads and interpret documents and drawings/specifications. Reads, comprehends and follows job instructions and/or protocols direction including verbal, written, diagramed, colored, etc. and other work related documents.
*Perform accepted/rejected activities for raw materials, components, and OEMs in SAP.
*Attend team meetings and provide feedback to the team. Provide guidance on lab and product related issues to Study Coordinators/Supplier Quality Engineers.
*Perform first article inspection on new parts/components. Train inspectors on various test methods, procedures and new policies as needed.
*Assess priorities and adjust own schedule if needed. Perform functional acceptance testing on products, per the applicable procedures and or test methods.
Required Knowledge, Skills and Abilities:
*High school diploma, or equivalent, is required. Associates or BS Degree in Science, Math, Business or related field is preferred.
*Minimum of 1 year in quality function or a BS or CQT required; experience working in an FDA regulated environment is required; medical device experience is preferred. Three year FDA regulated environment work experience in lieu of 1 year in a quality function is acceptable. Must demonstrate effective verbal and written communication skills.
*Must be able to perform basic math in all units of measure.
*Must demonstrate ability to work effectively in a team setting, be flexible, and exhibit a willingness to learn/ take on new tasks.
*SAP and Information Mapping experience preferred.
*Prior instron testing experience or prior training in one of the following instron operator's Course; Series IX, Merlin or Blue Hill is preferred.
*Must demonstrate ability to work independently and manage multiple tasks and priorities. High attention to detail is required.
*Must demonstrate ability to identify issues, effectively problem solve, and propose solutions.
*Proficiency in Microsoft Office Products or equivalent software application is preferred.