- Perform incoming inspection of raw materials in accordance with raw material specifications.
- Maintain all specification files (customer & raw materials)
- Makes final approval of products for shipment.
- Performs inspection and testing of products.
- Conducts finished product audits.
- Consults manufacturing on quality issues in Converting and Coating operations.
- Coordinates shipments with Customer Service, Shipping, Converting, and Quality.
- Records, charts and analyzes test data for comparison purposes.
- Tests finished products in accordance with Product Requirement Sheet, (PRS), and Tech 11.
- Types of tests include, but are not limited to peel, shear, tack and adhesion to release.
- May perform additional tests to meet customer's certification requirements.
- Reviews and approves testing performed by other Quality Assurance technicians.
- Prepares non-conforming reports and reports findings to Quality Engineer and Quality Assurance Manager.
- Input raw material and finished product test requirements in ERP system.
- Perform usage decisions in ERP system based on raw material and finished product test/inspection results.
- Initiate internal and supplier complaints for non-conforming material.
- Consults and communicates with managers on quality issues
- Provides the appropriate training and assistance, as needed.
- Excellent communication and able to collaborate and work well with others.
- Proficient use of Microsoft Office suite of products (Word, Excel).
- Knowledge of ISO standards (e.g. ISO 9001 and ISO
- Must be able to evaluate quality based on the use and interpretation of product/process specifications.
- Must be able to evaluate quality based on product specifications and alert manufacturing when product is non-conforming.
- Proficient technical writing
- 3 years' experience in Quality Assurance or Quality Control.
- 2 years' experience in medical device or industrial manufacturing.
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