+ Leads all Quality Assurance functions of the Pouch and Print Departments. + Oversees and assigns the workload and schedule of the Q.A. Inspectors. + Assists with all Equipment setup in Pouch and Print Room Departments as needed. + Oversees the Calibration of all the necessary Testing Equipment throughout the plant in conjunction with the Engineering Technician. + Conduct in-coming, in-process, first piece inspection, and final inspection and any other QA inspections required. + Knowledge of measuring equipment (micrometers, calipers) + Control of non-conforming materials and/or parts + Maintains material traceability and documentation + Ensure that tools, gauges, instruments, and other measuring and testing equipment are calibrated + Handles special order testing and inspection + Capable of carrying between 20 lbs. – 40 lbs. + Capable of standing 6-8 hours daily + Ability to start shift at 5:00 AM and work until 2:30 PM, M-F Saturday availability for overtime. No more than six hours. + Other duties as assigned Qualifications + Basic mechanical aptitude + Oversees calibration of Equipment and test equipment + Experience with ISO 13485 and 21 CFR Parts 11 and 820 for medical devices + At least 1 year of experience writing and reviewing CAPAs an NCRs + Knowledgeable in Microsoft Excel, and Word + Ability to train and direct lower-level inspectors in all phases of QA inspection + Proficient in all areas of inspection + Able to visually recognize colors and particulate as small as 0.8 sq. mm, must complete the Ishihara test for color blindness + 5 years of experience in Quality Assurance in a manufacturing environment with a recognized QMS + Proficient in written and spoken English (bilingual in Spanish) a plus Education Requirements: + High School Diploma, G.E.D or Equivalent + Preferred: Bachelor’s degree from a four-year college or university and one to two years related experience and/or training; or equivalent combination of education and experience Qualifications: + Certified by supervisor to be qualified to perform duties of this job