Job Description

The position performs inspections of outsourced and internal finished and semi- finished medical devices, components and raw materials to ensure that the product comply with product quality plans, specifications and requirements. RESPONSIBILITIES: Primary Duties Ensure compliance to federal and state laws, as well as company standards and specifications. Perform visual, functional and dimensional inspections across all stages of production. Communicate quality or concerns with urgency. Applies Good Manufacturing Principles (GMP) in all areas of responsibility including 21CFR820, ISO13485, EU MDR, MDD and CMDR Standards and regulations. Corrects or escalates quality or compliance concerns. Responsible for preventative maintenance activities Other Duties as assigned. Skills and Qualifications Solid understanding and experience using calipers, micrometers, hard gauging and other applicable inspection tools. Must be familiar with engineering drawings. Strong working knowledge of various mathematical concepts including fractions, ratios, and proportions. Ability to lift and/ or move 25 pounds occasionally. Specific vison abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus. Demonstrated ability to work independently with minimal supervision. Excellent organizational skills. Demonstrated ability to analyze and interpret information. Language and mathematical skills/Reasoning ability Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Mathematical Skills: Ability to add, subtract, multiply, divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situation.

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