The QA Technician is a paraprofessional who works in support of and under the direction of the quality engineer. The QA Technician analyzes and solves quality problems and is involved with quality improvement projects. These projects include automating the inspection process, creating inspection plans, performing first article inspections, automating records obtained and supplier development.
The QA Technician must possess the ability to perform and guide the QA Specialist(s) in incoming/receiving, calibration, in-process and final inspection testing of Electromed, Inc. electro-mechanical medical devices to assure that high standards of quality assurance are met.
The QA Technician embraces Electromed, Inc. Quality Policy which includes its core purpose, our niche, core values and quality mission statement. Position may assist in manufacturing and auditing, as appropriate.
* Detail oriented, motivated, self-starter.
* Ability to interact in a dynamic cross functional team environment.
* Ability to communicate effectively with external suppliers.
* Adherence in following documented procedures, work instructions, quality plans.
* Accurate recording and storage of test results and nonconforming material utilizing hard copy, as well as electronic filing techniques.
* Perform quality assurance testing of sophisticated custom engineered electro-mechanical medical devices including:
Dimensional inspection using attribute gaging (pass/fail), thread and plug gaging, overlays, gage blocks, micrometers, calipers, coordinate measuring machine (CMM) (for example Zeiss/Calypso), vision system and torque wrenches.
Electronic testing using hypot test equipment and multimeters.
Pressure testing using leak testing, pressure transducers, and sonic tension equipment.
* Programming of automated inspection equipment (CMM and vision).
* Auditing of processes.
* Perform other duties as assigned.
* Proficient with computers and the use of MS Office Suite of software tools and the filing of electronic records.
* Knowledge of basic mathematical operations (algebra, geometry, trigonometry), and perform measurement conversions.
* Knowledge of basic statistical terms and techniques, how to plot data and recognize out of control conditions.
* Understand the difference between accuracy and precision and be able to select the appropriate measuring tools and techniques.
* Understand concept of traceability (product, material, calibration).
* Ability to program automated inspection equipment.
* Working knowledge of ASME Y14.5M geometric dimensioning and tolerancing (GD&T) and understand the coordinate system.
* Able to select and follow appropriate sampling plans C=0, ANSI Z1.4, ANSI Z1.9.
* Understand the practices used on handling electrostatic discharge (ESD) materials.
* Basic knowledge of calibration.
* Understanding of FDA's 21CFR Part 820 Quality System Regulation and ISO 13485 Quality Management Systems helpful.
A minimum of four (4) years of higher education and/or work experience in either a technical, manufacturing, engineering or a quality related environment.
ASQ certification as a Technician or higher is a plus.
Ability to program automated inspection equipment, using CAD modeling. Ideally this includes experience with Solid Works, coordinate measuring machines (Zeiss-Calypso software with scanning capability) and vision systems (Keyence Image Dimension Measurement System) is a plus but will consider similar experience with this type of equipment.
Internal Number: QAT0120
About Electromed, Inc.
Electromed develops, manufactures, and markets innovative airway clearance devices that help people around the world breathe better, stay healthier, and lead active and fulfilling lives.