CQ Medical
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.
Responsibilities
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.
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.
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.
Working Conditions
50 lbs lifting required.
Hearing protection, safety glasses, safety shoes, and gloves required.
Exposure to biohazard required.
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 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.
Education and Experience
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.
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Responsibilities
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.
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.
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.
Working Conditions
50 lbs lifting required.
Hearing protection, safety glasses, safety shoes, and gloves required.
Exposure to biohazard required.
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 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.
Education and Experience
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.
#J-18808-Ljbffr