Description

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 3^rd 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.

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
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Requirements