Job Summary:
The R&D/QC technician reports to the QC/R&D Supervisor, and the primary duties of this position will be to work from formula documents, work instructions, and other established specifications to determine acceptance and rejection of products within company directives and operating procedures consistent with FDA, GMP, ISO 9001 and ISO 13485 guidelines.
The R&D/QC technician will set up, adjust, and align tests and safely run basic to moderately complex inspection equipment.
The R&D/QC technician will perform visual and dimensional inspections using visual standards and inspection tools. They will use procedures including sampling plans to conduct component and assembly inspections.
The R&D/QC technician provides traceable verification by completing inspection documentation or other documents for all components, assemblies, and/or product lots inspected, as required by inspection documentation.
The R&D/QC technician will also collect and analyze data using software programs. Additional responsibility will include the tracking of items within the calibration system and coordinating outside calibration of measuring and test instrumentation and or conducting internal documentation audits.
The R&D/QC technician maintains a clean work area and utilizes safe working practices.
The R&D/QC technician performs first piece and product inspections as necessary and coordinates nonconformance's creating and processing as needed.
The R&D/QC technician maintains control of items in the inspection process, and provides training and feedback to associates in quality practices, acceptance criteria, and measurement techniques. They Identify process/product discrepancies and communicate them through the quality system.
The R&D/QC technician prepares necessary reports, including documenting test results and statistics, maintains data using established procedures and file naming conventions, and retains records according to company policy and samples from inspections.
The R&D/QC technician is responsible for maintaining general housekeeping cleaning, sanitation and safe work area by utilizing all cleaning and tools necessary to keep the area clean and clear of debris, safe, neat and organized. Wears personal protective equipment as required.
The R&D/QC technician is responsible for implementing and maintaining the effectiveness of the quality system and ensures all activities are in compliance with Quality System requirements
