Quality Technician

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Full Time Monroe, OH, US

The Quality Inspector is responsible for inspecting temperature-controlled shipping boxes built and assembled by our Production team to ensure they meet engineering specifications, company quality standards, and the requirements of our pharmaceutical customers before release. This is a hands‑on, production‑floor role that plays a critical part in ensuring our packaging performs reliably for temperature-sensitive pharmaceutical shipments. Additionally, this role will support active‑side operations (14 CFR Part 21) by conducting incoming and in‑process inspections, as needed.

Essential Functions & Duties

• Perform incoming, in-process and final inspections of temperature‑controlled boxes assembled by the Production team, verifying dimensional, functional, and cosmetic conformance to engineering drawings, specifications, and work instructions.
• Use precision measuring tools (calipers, tape measures, gauges, etc.) to verify components and assemblies meet required tolerances.
• Verify correct components, materials, and labeling are used in accordance with the bill of materials (BOM) and applicable work instructions.
• Perform functional and performance checks as applicable (e.g., insulation integrity, latch/seal function, temperature monitoring device placement and function).
• Verification of any PCM conditioning shipments prior to shipment.
• Accurately document inspection results and maintain inspection records in the quality system.
• Identify, tag, and segregate non‑conforming product; initiate non‑conformance reports (NCRs) and support root cause investigation and corrective action activities.
• Communicate inspection results and quality issues clearly and promptly to Production Supervisors and the Quality Manager.
• Support first article inspections (FAI) for new products, engineering changes, or new customer programs.
• Assist with maintaining the calibration schedule and records for inspection tools and gauges.
• Support internal and customer quality audits by providing inspection records and traceability documentation.
• Perform work in accordance with the company's quality management system and applicable customer requirements for pharmaceutical packaging.
• Maintain a clean, organized, and safe inspection workstation, following 5S and safety practices.

Knowledge, Skills, & Abilities

• Ability to read and interpret engineering drawings, specifications, and work instructions.
• Working knowledge of basic inspection tools and measurement techniques (calipers, gauges, tape measures, etc.).
• Strong attention to detail and accurate documentation habits.
• Basic computer skills, including data entry into quality or ERP systems (e.g., MS Office, [ERP/QMS name]).
• Ability to work effectively and communicate clearly with the Production team, Supervisors, and Quality staff.
• Basic understanding of quality principles (root cause analysis, corrective/preventive action, 5S) preferred.
• Self‑motivated, reliable, and able to work independently with minimal supervision.

Education & Experience

• High school diploma or equivalent required;
  Associate degree in a technical, quality, or manufacturing‑related field preferred.
• 1–3 years of experience in a quality inspection role within a manufacturing or assembly environment.
• Experience in packaging, pharmaceutical, cold chain, or temperature‑controlled products preferred, but not required.
• ASQ Certified Quality Inspector (CQI) or similar certification a plus.

Physical Requirements

• Ability to stand and walk on the production floor for extended periods.
• Ability to lift, carry, push, or pull up to approximately 40–50 lbs (some temperature‑controlled containers are large and bulky).
• Ability to bend, reach, kneel, and climb as needed to inspect containers of varying sizes.
• Manual dexterity sufficient to handle inspection tools, small components, and documentation.
• Visual acuity sufficient to detect surface defects, read fine print/labels, and use precision measuring instruments.
• Manufacturing/production environment; may include…