QC Inspector Ld Plant - SPT Waukegan

JOB SUMMARY:

Responsible for the inspection of raw materials and finished goods (including medical products) using manual, visual, measurement and/or test equipment following company established procedures. Ensures compliance with established quality and reliability standards. Act as the first point of contact for quality control, production, and quality assurance assistance.

MAJOR RESPONSIBILITIES:

• Serve as a liaison between the QC Inspectors and Production on discrepancies and questions. Train employees on new and/or revised procedures. Mentor other inspectors, provide coaching and advice on day-to-day questions
• Lead and develop quality procedures and related documentation for Inspectors.
• Ensure device history records are reviewed and returned to Quality Assurance.
• Operate test equipment and perform simple measurement activities (using a ruler, caliper, eyeglass comparator, Tensile Tester, micrometer, etc.) per standard operating procedures.
• Identify and report deviations, defects, and non-conforming material found during inspections per established Accepted Quality Limits (AQL).
• Complete inspection documentation per applicable procedures.  Identify errors and omissions for correction.
• Review current procedures and recommend enhancements.
• Perform inspection of raw materials and finished goods.
• Perform stock checks and rework inventory when requested.
• Perform Line Clearance and First Article Inspections after product changeovers. Complete Line Audits including product recipe, setting/set-up, etc. to ensure acceptable product is manufactured to specification.

Education

• High School Diploma or equivalent.

Work Experience

• At least 2 year of quality control experience in a regulated industry.
• Experience adhering to ANSI/ASQC quality control guidelines.
• Experience adhering to FDA/QSR/ISO14551/ISO9001/ISO13485 guidelines.

Knowledge / Skills / Abilities

• Ability to perform basic math (addition and subtraction).
• Position requires:
  • Sitting, walking or standing for prolonged periods of time, with frequent bending and kneeling.
  • Close vision, distance vision, depth perception, and ability to adjust focus.
  • Working in hot and cold environments, (32F - 95F), and at heights.
  • Ability to regularly lift up to 50 lbs.