Quality Assurance Inspector II

The Quality Assurance Inspector II will be inspecting product to assure that it meets or exceeds the requirements set forth by customer specifications and quality acceptance criteria.

• Perform first article, in-process, and final product inspection using drawings, specifications, and/or related instructions.
• Read manufacturing prints and determine relevant features for verification of accuracy.
• Understand and complete Document Review Checklist (DRC) and Quality Inspection Report (QIR) accurately.
• Capture results data and store electronically in correct file folders.
• Correctly utilize / interpret generalized inspection equipment, to include micrometers, calipers, comparators, and related gages and equipment. May be involved in inspecting parts using advanced inspection equipment.
• Check out and return gages for each inspection.
• Assist with customer concerns and inquiries as they relate to product quality at EMS.
• Assist and / or instruct manufacturing personnel with checking product correctly as it relates to the customer inspection criteria.
• Maintain strict focus on accuracy, neatness, and thoroughness of product inspection and documentation of results.
• Identify non-conforming product and may complete or elevate to management non-conforming paperwork and product per requirements.
• Record production through Job Boss system.
• Perform other job duties as assigned.
• Support of the EMS Quality Policy and Quality Objectives.

This team member supports various activities that contribute to the overall EMS objective of compliance to FDA regulations & ISO 13485 requirements. Ongoing collaboration with additional EMS roles is required.

• A minimum of a High School diploma or GED with 2+ years of inspection or machining experience or an equivalent combination of education and experience is preferred. Some prior quality inspection experience is required.
• Experience in proper documentation/quality requirements for a regulated environment.
• Understanding of FDA and global regulations and standards (including guidance documents), ISO, GMP, and ASTM applicable standards related to validation and equipment controls.
• Works well under pressure.
• Ability to think critically and have a strong attention to detail.
• Have an understanding of relevant safety requirements.
• Must be able to work in a team environment.
• Must be able to speak, read and write in the English language.

• Good vision either natural or through correction (glasses/contacts lens) is needed for this position.
• Levels of monochromacy, also known as color blindness, must be known to establish appropriate risk for certain types of inspection that are dependent on color recognition.
• Able to lift or maneuver tools and material within your scope of responsibility, using or requesting proper and approved maneuvering equipment where necessary.