Lead Quality Assurance Inspector

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