Quality Control- 1st Shift

Fort Atkinson, WI

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Description

Job Summary: In-Process and Final Inspection of medical device products manufactured in facility Responsible for verification of packaged materials, sub-assemblies, finished products to Quality procedures and Quality standards. This may include verification of conformance to established standards and specifications. Essential Duties and Responsibilities: ·Performs in-process and final inspection of all product lines and areas for conformance to specifications (inspection procedures and engineering drawings); conducting visual inspection and testing components/assemblies in production. ·Perform basic visual inspection of shipping material & products according to established procedures. ·Verify Calibration status of critical equipment and instrumentation. ·Maintains and records quality testing information as part of a DHR (Device History Record). ·Maintain electronic quality documentation files such as, inspection records, within an electronic database. ·Document inspection results using Excel. ·Initiates NCMR’s (Nonconforming Material Report) for nonconforming material. ·Read and interpret documentation such as Standard Operating Procedures (SOP), PDAs and ECOs. ·Populate required inspection metric information. ·Prepare retain samples for storage. ·Completes all tasks within established guidelines. Understands and apply principles of GDP. ·Maintains work areas and equipment in a clean and orderly condition and follows prescribed safety regulations. ·Must be able to work in a Team environment, multi-task and communicate effectively. ·Interface with other functions and departments as required. ·When required perform Final Inspection activities § Inspect, measure and/or test manufactured devices to established methods and standards. § Utilize various inspection tools, such as rulers, DVMs,

Job Requirements

Competencies:

·       High school diploma or equivalent, 0 - 2 years’ experience in related position, or a sufficient combination of the two.

·       Proficient in the English language (speak, read, and write).

·       Good written and oral communication skills

·       Proficient in the use of basic Dimensional Measuring Tools.

·       Basic computer skills: Microsoft Office

·       Ability to perform basic math calculations (addition, subtraction, multiplication, and division).

·       Ability to read specifications, procedures, and engineering drawings, basic blueprint reading.

·       Oracle and MES experience preferred

·       Ability to lift up to 50 lbs.

·       Strong attention to detail

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