Quality Assurance
3 weeks ago
Job Description
• Must have 3+ years of inspection experience with various measurement tools (such as, vision systems, calipers, gauge pins,
and microscopes). 2+ years performing medical device inspection.
• Reading and understanding design drawings; analyzing and interpreting blueprints, work instructions, data,
manuals, and other materials to determine specifications, inspection and testing procedures, adjustments and
certification methods, formulas, and required measuring instruments.
• Inspecting incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and
returning unacceptable materials.
• Responsible for approving First Piece Inspection which shall verify that the set-up parameters in the injection
molding process are proper and producing acceptable parts. This inspection will be performed based on the Product Specifications for that product.
• Responsible for performing product inspection by following the Product Specifications and recommended
techniques for that particular product. Inspection consists of rounds of each machine and box/bag audits.
• Responsible for verifying, during product audits, that the product is packaged and weighed properly.
• Responsible for verifying that containers are properly labeled and bulk products are put into proper bins.
• Assists the Quality Manager in data collection, GR&R studies, calibration of inspection equipment, etc.
• Responsible for recording observations on the Record of Inspection form, routing all pertinent information required
per the Product Specification Sheet, and recording any information or problems that should be passed on to the
next shift’s Inspector. Responsible for reporting all out-of-specification, and non-conformances appropriately.
• Provide feedback to the supervisor regarding safety, fit, tolerance, quality, appearance, or questionable procedures
and practices.
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