Quality Engineer

JOB TITLE: Quality Engineer I

DEPARTMENT: Quality Control

REPORTS TO: Quality Manager

JOB SUMMARY:

Performs professional quality, validation, gaging, and quality engineering work for the company

Performs quality related tasks and final inspections on customer products to ensure that customer requirements are met. Participates in the execution of projects. Work is performed under direction of the Quality Director. Position relies on limited experience and exercises independent judgment to determine the best approach by using and interpreting policies and procedures. Position seeks technical guidance on unusual or complex problems or issues.

EXAMPLES OF ESSENTIAL FUNCTIONS:

• Participates in the design and development of projects; ensures that designs meet all requirements
• Reviews design drawings for tolerances, inspect ability, and quality of design issues; interprets and communicates dimensional data from technical drawings
• Participates in the execution of machine and process validations; performs validations; plans and analyzes statistical studies data provided by machinists; receives customer validation plans and performs actions required with oversight.
• Receives and logs customer complaints and non-conforming products; facilitates containment actions; tracks corrective actions progress
• Assists in the design and development of methods and tools for the test and inspection of products
• Creates Engineering Change Orders (ECO’s) and executes assigned tasks
• Creates non-conforming parts reports and manages the nonconforming parts log; assists in the disposition of rejected material
• Communicates with vendors, customers, and Operations personnel to address Quality related issues
• Responsible for accurately completing documentation (i.e. work travelers and inspection sheets)
• Maintains Quality files on suppliers
• Assists in Quality related staff training
• Understands and works toward Quality objectives and cost containment by optimizing the inspection process and identifying Quality bottlenecks that hinder production

MINIMUM QUALIFICATIONS:

Bachelor’s degree in engineering or related field; one to three years’ quality engineering experience desired; or an equivalent combination of education, certification, training, and/or experience.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Knowledge in the field of engineering and geometric dimensions and tolerances
• Knowledge of measuring tools, including but not be limited to, calipers, micrometers, depth gages, indicators, and plug and tread Go/No Go gages
• Basic Knowledge and understanding of ISO 13485 and FDA 21CFR820 as it pertains to the job
• Working knowledge of computer software including but not limited to Microsoft Outlook, Excel and Word, Adobe PDF, SolidWorks, in-spec metrology software, internet explorer, Visual Enterprise Resource Planning (ERP) software
• Skilled in basic math including but not limited to adding, subtracting, multiplication, division, geometric construction, practical algebra and metrics for the purpose of calculating material specifications
• Skilled in setting priorities that move projects through efficiently to achieve customer and quality objectives
• Skilled in working independently and following through with assignments with minimal direction
• Ability to read blueprints
• Ability to establish and maintain effective and cooperative working relationships with those contacted in the course of work
• Ability to learn and adapt to changing technology
• Ability to clearly communicate and understand information in English, both orally and in writing