Product Inspector

Datwyler•Middletown, NJ

About The Position

The Product Inspector is part of the Final Control team and works in shifts, performing visual and physical inspections of finished products according to company and customer requirements. The role controls, reviews, releases, or blocks end products and monitors the production process by completing prescribed tests and checks against applicable specifications. The QC Lab is outside production at First Line; however, the lab is within the production area and the same protective-clothing rules apply. Job holders rotate between labs. In addition to routine tests for each production batch, additional standard or non-routine tests may be required in response to customer complaints, production deviations, or validation work. The inspector examines products using visual, tactile, dimensional, and mechanical methods; reviews batch documentation for compliance with applicable GMP rules; records results in SAP; and assigns a final batch status based on inspection findings and predetermined specifications.

Requirements

Knowledge of office software and company-specific software.
Thorough product knowledge, including design, compound, wax code, materials, and quality characteristics identifiable by touch.
Knowledge of the production process, product defects, specifications, error codes, and customer-specific requirements.
Applied knowledge of GMP guidelines and company guidelines, including safety.
Knowledge of English.
Ability to operate a PC and laboratory measuring equipment.
Ability to perform concentrated inspections using a loupe and microscope and conduct dimensional and mechanical testing.
Ability to distinguish minor contaminants from 0.02 mm² and recognize color differences and various defects.
Ability to set up and operate a camera projector for routine dimensional measurements.

Responsibilities

Inspect finished products visually with a loupe and microscope, by touch, and with instruments to detect defects and help prevent production loss.
Determine work sequence according to the delivery list and become familiar with product types and their specifications.
Assess and classify defects according to predetermined specifications.
Check siliconization of finished and semi-finished products by touch and with an Infrared Spectrophotometer.
Inspect packaging seals, prints, and labels.
Perform product-dependent mechanical tests prescribed in SAP, including needle-guard rebound and adhesive-force tests, self-sealing, fragmentation, and puncture-force tests.
Enter test results in SAP.
Measure finished-product dimensions using appropriate measuring instruments, including flange thickness, total height, diameters, eccentricity, and wall thickness.
Determine trends based on previous tests, measurements, and acquired insights, and report them to the QC Manager or designee.
Review batch documentation for correctness, completeness, and conformity with applicable GMP rules.
Verify that required process steps have been completed and registered for the relevant product code.
Review retreatment forms for rework, Line Clearance documents, checklists, and other forms; report deviations or inadequate data to the QC Manager or designee.
Assign final status to finished products by releasing or blocking batches according to inspection results and specifications.
Complete event notification forms for out-of-trend and out-of-spec results and maintain lists related to activity follow-up.
Conduct non-routine testing in response to customer complaints and for validation work.
Monitor the production process by performing prescribed tests and checks against specifications.