Responsible for raw material incoming inspection; manufacture in-process and final inspections and other quality assurance monitoring activities (e.g. auditing). Responsible for environmental and water system sampling.
Principal Duties and Responsibilities
•Performs testing and/or inspection of raw materials, components, in-process sub-assemblies, and final products as specified on drawings and/or procedures. Retrieves device history records (DHR) when required.
•Performs environmental and water system sampling.
•Monitors process to be in accordance with procedures.
•Audits procedures and if required, generate an engineering change requests.
•Identifies discrepancies and documents in a nonconformance report. Performs quarantine of nonconforming material.
•Generates an inspection report of the inspections performed in the assigned inspection area.
•Monitors for GMP/QSR & ISO compliance on the assigned area and reports the nature of violation writing to immediate supervisors.
•Certifies training of product related operations to assure they perform as per procedures and drawings.
•Other tasks assigned by Quality Supervisor and/or upper management.
Expected Areas of Competence
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
•Language Skills: Able to read and write in English and Spanish.
•Mathematical Skills: Able to perform math calculations (sum, subtract, multiplication, division), basic statistic (sample size determination ANSI/ASQ Z1.4 MIL-STD-105E AQL) and spreadsheet calculations (sum, subtract, multiplication, division, tables, formats, etc.).
•Reasoning Ability: Able to apply common sense understanding to carry out detailed but uninvolved instructions and to deal with problems involving a few variables.
•Physical Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
oMobility: (Ability to assist in the movement of objects)
• Sitting• Walking • Standing
oDexterity: (Ability to manipulate objects)
• Reaching • Grasping
oVisual: (Ability to recognize, register, and respond)
• Reading / Close-up work
•Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
oThe noise level in the work environment is usually moderate.
•Associate degree in science related discipline or equivalent.
•At least 1 year of quality related tasks and/or quality control/assurance experience.
•Knowledge of medical devices GMP/QSR & ISO regulation and application.
•Computer literate (Word, Excel, Power Point, Outlook, etc.).
•Bilingual (English and Spanish).
•Basic knowledge on Root Cause Analysis tools (fishbone, etc.).
•Knowledge in the use of mechanical and electrical measuring devices (calipers, plug gage, thread gage, depth gage, micrometer, multi-meter, LCR digi-bridge meter, oscilloscopes, etc.).
•Knowledge on drawings reading and interpretation.
•Knowledge on quality sampling size calculations.
Up to 10%, if necessary.