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Lead Quality Assurance Inspector
2 months ago
Job Location
Peelmaster - Niles - Niles, IL
Description
- 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
- 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
- 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
- Certified by supervisor to be qualified to perform duties of this job