Quality Inspector II

Job Summary and Objectives

The Quality Control Inspector will work with other NextPhase personnel to provide various inspection services within the bounds of our quality management system, following defined AQL inspection sampling plans. The Inspector will follow work instructions and quality inspection plans and inspect components to specific requirements utilizing various tools, including but not limited to visual inspection, digital height gauges, calipers, optical comparators, vision systems, durometers, and more. The Inspector is required to follow Good Documentation Practices and work in compliance with our quality management system that is based on ISO 13485 and 21 CFR 820. The Inspector may also provide in-process inspection services for assemblies and finished medical devices.

Essential Duties and Responsibilities

• Performs incoming material inspection following work instructions and component quality inspection plans.
• Follows specific AQLs where identified.
• Performs first article inspections.
• Properly dispositions and labels inspected materials.
• Performs in-process inspection on subassemblies and finished devices as required.
• Utilizes a variety of inspection tools including but not limited to visual inspection, digital height gauges, calipers, optical comparators, vision systems, durometers, and more.
• Works with operators and supervisors on quality policies and procedures; assists in training of employees on new policies and procedures.
• Determines acceptability of rework by conducting inspections and physical tests of reworked product.
• Documents finished product status by recording and summarizing raw materials, in process, and finished product inspection and physical test data; updating quality assurance databases as required.
• Maintains quality assurance operations by following quality assurance policies and procedures, reporting needed changes.
• May participate in audits.
• Perform packing line and manufacturing inspection as needed.
• Perform sampling and testing of components, materials, and equipment.
• Ensure that raw materials and products meet company standards.
• Determine methods, sequences, and procedures necessary for inspection.
• Interpret manufacturing drawings, diagrams, and specifications to approve or reject units or systems.
• Adapt measuring devices and procedures.
• Apply approval or rejection labels to raw materials once analytical data is evaluated.

Required Qualifications and Work Experience

• 2-5 years in medical device quality assurance or related field.
• A working understanding of ISO 13485 and FDA Quality System regulations.
• Understanding of inspection practices and AQL sampling.
• Use of inspection tools required.
• Proficient use of optical comparators, vision systems, height gauges, durometers, and other metrology equipment.
• Working knowledge of ISO 13485 and FDA QMSR.
• Understanding of statistical sampling and AQL methodologies.
• Ability to communicate ideas and information clearly, effectively, and frequently (oral and written) in English.
• Ability to work with minimal supervision autonomously and in a team environment.
• Take responsibility for task and time management.
• Attention to detail to understand and meet the requirements.
• Ability to work with others collaboratively.

Preferred Qualifications and Work Experience

• ERP experience is required.
• ASQ Certification is beneficial.