Quality Control Inspector

Description

Division/Department:
Quality Assurance

Reports to:

Quality Assurance Manager

To ensure that the products made by Artemis meet our quality guidelines and satisfy the customers’ specifications and expectations throughout all stages of manufacturing.

• Reading and understanding design drawings; analyzing and interpreting blueprints, work instructions, data, manuals, and other materials to determine specifications, inspection and testing procedures, adjustment and certification methods, formulas, and required measuring instruments.
• Inspecting incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials.
• Approving First Piece Inspection which shall verify that the set-up parameters in the injection molding process are proper and producing acceptable parts. This inspection will be performed based on the Product Specifications for that product.
• Performing product inspection by following the Product Specifications and recommended techniques for that particular product. Inspection consists of rounds to each machine and box/bag audits.
• Verifying, during product audits, that product is packaged and weighed properly.
• Verifying that containers are properly labeled and bulk products are put into proper bins.
• Stamping approved boxes/bags of product with inspection stamp, verifying that boxes/bags are properly sealed, and verifying appropriate boxes are properly stacked on skids, if required.
• Ensuring that once a mold is pulled from a machine, indicating the completion of a production run, that the First and Last shots are retained and stored properly.
• Assisting the Quality Manager in data collection, GR&R studies, calibration of inspection equipment, etc.
• Recording observations on the Record of Inspection form, routing all pertinent information required per the Product Specification sheet, and recording any information or problems that should be passed on to the next shift’s Inspector.
• Reporting all out of specification, non-conformances appropriately.
• Providing feedback to supervisor regarding safety, fit, tolerance, quality, appearance or questionable procedures and practices.
• Maintaining safe and healthy work environment by following standards and procedures, complying with legal regulations. Familiar with federal regulatory agencies and international quality standards.
• Arriving at work in a timely manner to receive daily job assignment and be at workstation prior to the start of shift

• Recommends improvements in productivity and organization within respective departments.
• Segregates and documents defects as they are discovered during inspection.
• Advises Quality Assurance Manager on findings that pertain to quality.
• Assists others in lifting and moving of heavy objects (e.g., moving boxes of parts during or after inspection).
• Updates job knowledge by participating in educational opportunities, reading technical publications, etc.
• Follows regulatory requirements as they pertain to assigned job responsibilities.
• Works well with others.
• Performs other duties as required.

• High School diploma or equivalent.
• 3+ years of inspection experience with various measurement tools (such as, vision system, calipers, gauge pins, and microscope). 2+ years performing medical device inspection (With a higher degree of specificity and regulatory rigger).
• Experience reading and understanding design drawings.
• Experience using quality measurement tools such as pin gauges, microscopes, etc.
• Strong vision, and good eye-hand coordination to effectively use various measuring instruments.
• Must be detail oriented, and able to work with minimum supervision.
• Must be able to work cooperatively in a team environment.
• Knowledge of computer software (MS suite, measuring systems), and spreadsheet software required.

• Specialized training: ASQ Certification CQI or CQT desirable, but not required
• Prefer experience with vision measurement systems, including programming (e.g., Keyence or Micro Vu).
• Some college courses or certificates in Quality Assurance field of study.
• 2+ years’ experience performing medical device inspection and using a Quality Management System database.

• Judgment:
  Makes sound decisions; bases decisions on fact rather than emotion; analyzes problems skillfully; uses logic to reach solutions.
• Knowledge and use of computers and various software (Microsoft Word and Excel, measurement system), and ability to input and understand data. This will require long periods of sitting and manipulation of computer equipment, such as a mouse and keyboard. Improper posture can lead to fatigue and other problems.
• Cooperation/ Teamwork:
  Works collaboratively and effectively with others to get a job done; responds positively to instructions and procedures; shares critical information with…