Quality Control Inspector

Job Summary: The Quality Control Inspector I is responsible for inspecting, testing, and auditing raw materials and finished products, as well as releasing finished products. * Attention to detail is an expectation. * Demonstration of commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all other documented quality processes and procedures. * Inspect and release raw materials, components, sub-assemblies, and finished devices according to procedure. * Drives continuous improvement activities with cross-functional team members. * Generate non-conformances and escalate to the Material Review Board in a timely manner. * Interacts with production areas, manufacturing and design engineering, marketing, quality, and management. Job Duties: * Promotes a work environment of continuous improvement that supports CQ Medical's Quality Policy, Quality System, and the appropriate regulations. * Assists with communicating business-related issues or opportunities for improvement to management. * Accountable for compliance with applicable US and International regulations and directives including, but not limited to, Food & Drug Administration (FDA), Canadian and European Union regulations. * Works in a team environment to achieve metrics. * Interprets engineering drawings, schematic diagrams, sampling tables, or formulas and confers with management or engineering staff to determine quality and reliability standards. * Selects products for tests at specified stages in production process, and tests products for variety of qualities such as dimensions, performance, mechanical, or chemical characteristics. * Records test data, applying statistical quality control procedures using GMP documentation practices. * Recommends modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability. * Quarantines all incoming material until testing is accepted. * Quarantines all non-conforming material during any step of the manufacturing process until the Material Review Board dispositions the material. * Purging of records as required. * Maintains a neat and organized work area. * Remains current on all required training. * Conducts calibrations and works with 3rd party calibration providers to ensure inspection equipment meets specifications. * Conducts transactions in the Quality Management System and/or ERP system to detail the disposition of incoming and in-process materials. Working Conditions: * 50 lbs. of lifting required for this role * Hearing protection, safety glasses, safety shoes, and gloves are required for this role * Required exposure to biohazard Job Qualifications: * 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 auditors or employees of our organization. * Ability to interact effectively with individuals and teams. * Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, percent, and interpret bar graphs. * Decision-making ability. * Ability to use testing equipment. * Must be able to manage multiple tasks and perform with accuracy and a high attention to detail. * Ability to identify priorities and function independently required. * Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Identify various discrepancies (product, process, documentation, etc.) * Analytical and problem-solving skills. * Computer proficiency, including data entry. MS Office Suite (Word, PowerPoint, and Excel) experience required. Education and/or Experience * High school diploma or general education degree (GED). * Medical device or manufacturing experience a plus. * Preferred demonstration of leadership.