• 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