QA Inspector

ASO, LLC• Sarasota, FL, US, FL

About The Position

The QA Inspector implements the quality assurance program for non-conforming products and raw materials, ensuring quality system requirements and standards are met, including FDA, ISO, and MDD requirements. The role performs inspections, investigates defects, supports validations and equipment calibration, maintains a compliant quality environment, and documents test results in accordance with good laboratory practices. The inspector is cross-trained in inspection, receiving inspection, and various QA supervisory functions, and may assist with customer complaints, work-order administration, and special projects.

Requirements

High school diploma or equivalent preferred.
2+ years of previous QA experience in a manufacturing environment preferred.
Ability to speak, read, and write in English.
Basic math competencies, including addition, subtraction, multiplication, and division.
Ability to interpret instructions in written, oral, diagram, or schedule form.
Computer literacy and proficiency with MS Office and Outlook.
Prior use of MRP systems is highly required.
Detail-oriented, with sound written and verbal communication skills.
Ability to work a flexible schedule.
Ability to stand for a full shift of 8 to 12 hours; lift, push, and pull up to 50+ pounds; and frequently walk, stoop, kneel, bend over, and grasp objects with both hands.
Visual acuity or corrective vision, including close, distance, and color vision.
Initiative, common sense, and analytical problem-solving characteristics.
Willingness and ability to be cross-trained in other QA job functions.
Ability to report to work on time consistently and regularly.

Nice To Haves

Ability to speak, read, and write in Spanish.

Responsibilities

Perform root cause analysis on non-conforming products and process defects to support continuous improvement.
Inspect rejected components, sub-assemblies, and finished products, and prepare Material Rejection and Purge Reports for non-conforming material trending.
Prepare protocols and coordinate and perform data collection and analysis for process and product validation studies.
Assist with calibration of test and measurement equipment and maintain the Calibration Log and applicable Calibration Records.
Monitor and maintain a quality environment compliant with applicable quality and regulatory requirements.
Cross-train to perform quality inspection and receiving inspection duties, including inspecting and releasing sterilization loads, reconciling sterilization loads, and conducting in-process and final inspections in Converting and Packaging.
Test returned consumer samples to resolve customer complaints.
Document test and analysis results in accordance with good laboratory practices (GLP).
Cross-train in QA supervisory functions, including employee training on FDA, ISO, and MDD requirements and handling customer complaints.
Assist with data entry, review work orders, and file completed work orders.
Assist the QC Supervisor with special projects as required.
Report any action that puts a process or product at risk.
Perform other duties as assigned.