Product Inspector

Datwyler•Middletown, DE

About The Position

The Product Inspector is a member of the Final Control team and performs visual, tactile, dimensional, and mechanical inspections of finished products and semi-finished products according to company and customer requirements. The role includes evaluating products against predetermined specifications, identifying defects and trends early, entering test results in SAP, reviewing batch documentation for compliance with applicable GMP rules, and assigning a final release or blocked status to batches. The position also involves conducting non-routine tests in response to customer complaints, production deviations, or validation work. The QC Lab is outside production at First Line, while this lab is within production; protective-clothing rules apply. Product Inspectors rotate between labs and work in shifts.

Requirements

Knowledge of office software and company-specific software.
Thorough product knowledge, including design, compound, wax code, materials, and quality characteristics assessed by touch.
Knowledge of the production process.
Thorough knowledge of 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 concentrate while inspecting under a loupe and microscope and performing dimensional and mechanical tests.
Ability to visually 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 identify defects and prevent production loss.
Determine work sequence based on the delivery list and familiarize themselves with product types and specifications.
Assess and classify defects according to predetermined specifications.
Check siliconization of finished and semi-finished products by touch and with an Infrared Spectrophotometer.
Check packaging bag 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 end-product dimensions using instruments, including flange thickness, total height, diameters, eccentricity, and wall thickness.
Determine trends from 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 were completed and registered, review retreatment forms and Line Clearance documents, and check relevant lists and forms.
Report deviations or inadequate data to the QC Manager or designee.
Assign final status to end products by releasing or blocking batches based on test results, checks, and specifications.
Complete event notification forms for out-of-trend and out-of-spec results and maintain lists related to activity follow-up.
Control, review, release, or block end products and monitor production by performing prescribed tests and checks.
Conduct non-routine tests related to customer complaints, production deviations, and production-process validation work.