Objective

The QC inspector will inspect, review, release or reject semi-finished and finished products. The visual inspection of semi-finished and finished goods is part of the overall inspection plan to assess the quality of the products. When required, also simple dimensional checks have to be performed.

Most Important Tasks

Visual inspection of semi-finished and finished products

• Inspection, visually, by feeling and using instruments, of finished products in order to achieve production within standards and detect defects (“out of trend” and “out of spec”) early in order to avoid production loss. Tasks:
• Determine the work sequence in function of what needs to be delivered,
• Familiarize yourself with the products to be inspected and the associated specifications;
• Visual inspection of (semi-)finished products (using a loupe and microscope);
• Assessing and classifying the defects found according to the specifications;
• Checking the degree of siliconization of the (semi-)finished products either by means of touch (based on experience) and/or using an Infrared Spectrophotometer;
• Checking the quality of the bag seals, prints and labels on the packaging of the end product;
• Performing various product-dependent mechanical tests as prescribed in the SAP system;
• Functionality of needle guards by means of rebound tests, determining the adhesive force of needle guards by means of a digital force gauge; self-sealing, fragmentation and puncture force;
• Entering test results in SAP.

Dimensional inspection of finished products using measurement instruments

• Measuring finished products using various measuring instruments in order to determine whether the
• Dimensions of finished products are within the standards. This means, among other things:
• Measurement of flange thickness and total height by means of a digital dial gauge;
• Checking diameters with the aid of a caliper or mold;
• Detecting and measuring eccentricity, wall thickness, etc. using a projector

Report observations to the production departments, the team leader or QC Manager

• Determine trends based on previous tests and measurements, and reporting observations to the production departments, the team leader or QC manager.

Review of electronic batch record

• Checking and assessing the electronic batch record for correctness, completeness and conformity with the applicable
• GMP rules in order to take corrective action if necessary. This means, among other things:
• Assess whether all process steps have been carried out and registered as prescribed for the relevant product code;
• Checking Line Clearance information for the different production steps;
• Checking open Quality Notifications
• Report deviations or inadequate data to the QC manager or designee

Take final usage decision for finished based on test results and checks against the predetermined specifications. This may include:

• Initiating a quality notification to report out of trends and/or out of specs,
• Granting a final status to the end products: release or reject (out of trend or out of Spec).

Your Responsibilities

Control, review, release or block finished products and monitor production process by performing prescribed tests and checks according to certain Specifications. Conducting non-routine tests in response to customer complaints and validation work. The job holders belong to the Quality Control team and work in shifts. They are the specialists of the visual and physical inspection of the finished products according to company and customer requirements. The QC Lab is located inside the cleanroom. Therefore specific gowning requirements apply. . In addition to the routine standard tests that come with every production batch additional standard tests may be required upon request as a result of customer complaints, production deviations or to support validations of the production process amendments.

Your Profile

• Highschool diploma or GED required. Associate’s degree in scientific field preferred.
• Knowledge of office software and company-specific software.
• Thorough product knowledge (design, compound, washing code, material) and understanding of the production process.
• Thorough knowledge of product defects, specifications, and where applicable customer-specific requirements.
• Understanding of GMP guidelines and company guidelines including safety regulations.
• Able to operate a PC and simple laboratory measuring equipment (e.g. dial gauge).
• Concentrated performance of the inspections (under magnifying glass), dimensional and mechanical testing.
• Ability to distinguish visually, minor contaminants (size as from 0.02mm²), color differences and various defects.