QA Inspector - El Paso

ASO, LLCSarasota, Sarasota, FL, US, FL
Onsite

About The Position

Responsible for the implementation of the quality assurance program as it relates to non-conforming products and raw materials ensuring quality system requirements and standards are met including FDA, ISO and MDD requirements.

Requirements

  • Able to speak, read, and write in English; and possess basic math competencies (add, subtract, multiply, and divide).
  • Able to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Must be computer literate, able to proficiently use MS Office, and Outlook.
  • Prior use of MRP systems highly required.
  • Must be detail oriented, possess sound communication skills both written and verbal, and able to work a flexible schedule.
  • Able of standing for a full shift (8 to 12 hours); able to lift, push, pull up to 50+ pounds; and walk, stoop, kneel, bend over, and grasp objects with both hands on a frequent basis.
  • Visual acuity or corrective vision required for this position including close vision, distance vision, and color vision.
  • Possesses initiative, common sense and analytical problem-solving characteristics.
  • Demonstrates willingness and ability to be cross-trained in other QA job functions.
  • Ability to report to work on time on a consistent and regular basis.

Nice To Haves

  • Ability to speak, read, and write in Spanish a plus.

Responsibilities

  • Performs root cause analysis on non-conforming, products and processes defects for continuous improvement
  • Performs inspection of rejected components, sub-assemblies and finished products and prepares Material Rejection and Purge Reports for non-conforming material trending.
  • Responsible for preparing protocols, coordinating and performing data collection and analysis for process and product validation studies.
  • Assists with the calibration program for all test and measurement equipment and maintaining the Calibration Log and applicable Calibration Records.
  • Responsible for monitoring and maintaining a quality environment compliant with all applicable quality and regulatory requirements.
  • Cross-trained to perform all quality inspection and receiving inspection positions to include inspect and release sterilization loads, reconciliation of sterilization loads and in-process and final inspection in both Converting and Packaging departments.
  • Test returned consumer samples to resolve customer complaints.
  • Document results of tests, analyses in accordance with good laboratory practices (GLP).
  • Cross-trained in various QA Supervisory functions to include employee training on FDA, ISO and MDD requirements and handling customer complaints.
  • Assists with data entry, review of work orders and filing completed work orders.
  • Assists QC Supervisor with special projects as required
  • Other duties as assigned
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