US, US, OH - West Carrollton
Minimum Level of Education Required: High School/Equivalent
Percentage of Travel: No travel required
Location: OH - West Carrollton
The Quality Technician is responsible for any activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyzes data and documentation. Primary support functions are inspection (e.g. first article), data collection, maintenance of quality records, analyzing and solving problems, administration of quality systems such as Non-Conforming Material Reports, Repair Action Plans, and any other quality function deemed appropriate by Quality Leadership.
ESSENTIAL JOB FUNCTIONS
The Quality Technician is responsible for Quality Inspection, Quality Engineering Support, and Calibration / Metrology services in support of production, including development, implementation, improvement and maintenance of SPC functions for production and quality systems.
Quality Technician will support the development of manufacturing processes, inspection and testing plans, risk analysis and process validation to ensure the quality of new and modified products and processes in a CNC Manufacturing Environment.
Quality Technician will adhere to industry best practices in addition to their duties being performed in compliance with applicable regulations and standards including FDA Quality System Regulation 21: CFR 820, ISO 13485, and the European Medical Devise Directive.
DUTIES AND RESPONSIBILITIES
Inspection: Technician will be responsible for performing incoming material and component inspection as directed by inspection plans. Technician shall be proficient in use of hand inspection tools such as calipers, micrometers, height gauges, plug and pin gauges. Additionally, technician shall use Coordinate Measurement Machines (CMMs), Vision Systems (MeasureX / MeasureFIT), and Keyence.
Calibration: Technicians shall perform calibration services. This will include the need to inspect, test, maintain and repair a variety of inspection equipment to ensure measurement accuracy. Any measurement errors must be quickly identified and corrected. Technicians must compile, measure and record data from each instrument for other technicians, managers, and engineers to review.
Maintains the gauge calibration database. Technicians will ensure gauges and gauge kits are prepared and available for production and process development.
Process Development Support: Technician shall support Manufacturing Engineers, Quality Engineers, Programmers and Machinists during the development, assembly, troubleshooting, prove out, capability studies, first article inspection, process validation or test method validation. This shall include planning inspection methods, inspecting parts, training machinists and operators, and troubleshooting inspection methods on the CMM, vision systems, Keyence, Oasis, or other methods. With minimal supervision, design effective and efficient inspection techniques for First Articles, Custom Gages, Investigations and Test Parts. Will develop inspection procedures including manufacturing plans and work instructions.
Production Support: Technician shall support production by providing guidance to operators on inspection methods, metrology, gauging, etc. Technicians shall facilitate Statistical Process Control for the facility including escalation of abnormal events such as out of tolerance or special causes. Participates in NCR process and MRB process.
Support other work of the Q.E. Department, as required.
Perform duties in compliance with applicable FDA and state regulations as well as standards including, but not limited to, ISO 13485, MDD 93/42 CEE.
Computer Skills: Demonstrated experience using Microsoft Office including Word, Excel, Outlook, and Explorer. Understanding of metrology inspection programs such as PC DMIS, MeasureFit, MeasureX, GeoMeasure, Gage Insite, etc.
Language Skills: Excellent written and oral communication skills, with ability to write reports and correspondence required.
Mathematical Skills: Full understanding of arithmetic, geometry and trigonometry is required.
Reasoning Ability: Possess ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
American Society for Quality (ASQ) certifications, Certified Quality Improvement Associate (CQIA), Certified Quality Inspector (CQI), or Certified Quality Technician (CQT) is preferred.
Associates degree in a technical discipline is preferred