Professional - Quality Assurance Inspector

Job Description: Job Summary

With direction from the QA Inspection Supervisor(s) and Quality Management ensure that daily inspection priorities are processed in the department (in-process, final and receiving inspections).

Principal Duties And Responsibilities

Perform in-process and finished goods packaging, and sterile shipment inspection of catalog items distributed.

Perform routine in-process inspection tests to ensure proper seal integrity of sterilized packaged product using various instruments: burst tester, pull tester, torque tester.

Interact with packaging and assembly personnel to improve on overall Quality of product entering into the QA Inspection department, reducing rejections found and reported in QA.

Perform in-process inspections or audits inside a clean-room environment.

Complete and maintain all QA paperwork in accordance with established procedures and Good Manufacturing Practices (GMP's).

Perform incoming inspection of component parts, raw materials, and resale goods not requiring basic inspection tools: caliper, micrometer, thread gauges.

Follow written procedures and blueprints utilized for inspection and ensure they are kept current and adequate for the inspections performed.

Interact with personnel from departments outside of the Quality Inspection department, i.e. Manufacturing, Materials, Engineering, etc

Generate Non-conformance Reports for submitted product found out of specification.

Using typical MS Office software (Word, Excel, and Outlook) create and perform simple data entry tasks and procedure changes as requested by QA Management.

This is not an exhaustive list of duties or functions and might not necessarily comprise all of the essential functions for purposes of the Americans with Disabilities Act.

Expected Areas Of Competence (i.e., Knowledge, Skills And Abilities)

Ability to use simple hand-held measuring devices (micrometer, caliper) and test instruments (burst, pull and torque testers).

Ability to read standard operating procedures and packaging configuration drawings; basic understanding of engineering drawings required.

Working knowledge of sampling techniques (e.g., ANSI Z1.4.), Good Manufacturing Practices and other regulatory standards required.

Education/Experience Requirements

High school Diploma or GED required plus three to five years of experience as a Quality Inspector or as a manufacturing Operator or Assembler, or an equivalent combination of education and experience.

Experience working in an inspection department for a GMP, or other regulated industry, is a plus.

Prior final packaging inspection experience is required; working in a clean-room environment is a plus.