The Quality Technician will perform a variety of inspection and quality tasks in support of manufacturing operations and new product development activities. Ensure compliance with the RefleXion Medical Quality Management System (QMS).
Complete inspection of incoming materials including machined components, sheet metal parts, mechanical assemblies, printed circuit board assemblies, fasteners, and adhesives, per engineering drawings, specifications, and inspection plans.
Review supplier provided documentation including certificates of conformance, material certifications, and special process certifications.
Complete material acceptance and rejection transactions in MRP system.
Coordinate MRB activities and initiate NCR’s as required to ensure the proper disposition of non-conforming materials as required in the QMS.
Perform in-process and final inspections per inspection plans as required.
Coordinate calibration and preventive maintenance activities with outside suppliers.
Perform and/or participate in quality system audits as assigned, report findings, and make suggestions for improvement.
Support new product development activities as needed.
Perform all other duties as assigned.
Minimum of 5 years of inspection experience, preferably in the medical device industry.
Understanding of 21 CFR 820 Regulations and ISO 13485 Standards.
Ability to read and interpret engineering drawings and understand GD&T.
Working knowledge in the use of standard metrology tools including surface plates, calipers, micrometers, height gages, bore gages, indicators, pin gages, and gage blocks.
Experience with coordinate measuring machines (CMM), vision systems, and optical comparators.
Understanding of statistical process control (SPC)
Excellent verbal and written communication skills with attention to detail.
Must be motivated and work with minimal supervision in a fast-paced environment.
Computer skills including Microsoft Office (Word & Excel), email, and other common programs.