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 elevate to the Material Review Board in a timely manner.
• Interact with production areas, manufacturing and design engineering, marketing, quality, and management.

• 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.
• Interpret engineering drawings, schematic diagrams, sampling tables, or formulas and consult 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 a variety of qualities such as dimensions, performance, mechanical, or chemical characteristics.
• Records test data, applying statistical quality control procedures using GMP documentation practices.
• Recommend modifications of existing quality or production standards to achieve optimum quality within limits of equipment capability.
• Quarantine all incoming material until testing is accepted.
• Quarantine 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.
• Conduct calibrations and work with third‑party calibration providers to ensure inspection equipment meets specifications.
• Conduct transactions in the Quality Management System and/or ERP system to detail the disposition of incoming and in‑process materials.

• 50 lbs lifting required.
• Hearing protection, safety glasses, safety shoes, and gloves required.
• Exposure to biohazard required.

• 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 manage multiple tasks and perform with accuracy and a high level of attention to detail.
• Ability to identify priorities and function independently.
• 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.

• High school diploma or general education degree (GED).
• Medical device or manufacturing experience a plus.
• Demonstration of leadership preferred.

Location:

Newark, DE – Bridgeport, NJ. Salary range: $134,700–$224,500.