Our client, a medical device contract manufacturing company, has an immediate opening for a Quality Control Inspector. 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.

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.

Requirements:

• 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.
• Ability to learn new tasks quickly.
• Attention to detail to understand and meet the requirements.
• Ability to access, open, and save files to a computer.
• Ability to work with others collaboratively.

Education and Experience:

• 4+ 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.
• ERP experience is beneficial.
• Use of inspection tools required.