Product Inspector (Middletown, DE, US)

Datwyler; Town of Middletown (NY); On-site; USD 25,000 - 39,000; Full time

Job summary

Datwyler in Middletown, NY is seeking a Product Inspector to visually inspect end products, perform dimensional and mechanical tests, and ensure compliance with GMP standards. You will document results in SAP, manage batch records, and participate in final product status decisions.

The role requires familiarity with lab measurement tools, calibration, and adherence to safety as part of the Final Control team working in shifts across production.

Qualifications

• Knowledge of office software and company-specific software.
• Thorough product knowledge (design, material, quality knowledge through touch).
• Applied knowledge of GMP guidelines and company safety.
• Knowledge of English.
• Ability to operate PC and lab measuring equipment.

Responsibilities

• Inspecting end products visually and with instruments to ensure production within standard and detect defects early.
• Determine work sequence based on delivery list.
• Familiarize with product types and specifications.
• Assess and classify defects per specifications.
• Check siliconization, bag seals, prints and labels.
• Perform mechanical tests per SAP instructions and enter results in SAP.
• Test needle guards and measure adhesion with a force gauge.
• Enter test results in SAP.

Skills

Visual inspection

Dimensional testing

Quality control

GMP knowledge

English proficiency

Equipment operation

Tools

Infrared Spectrophotometer

SAP system

Caliper

Camera projector (MicroVu)

Digital force gauge

Job description

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Datwyler’s high-tech elastomer components make a vital contribution to the safety, reliability and functionality of critical systems in billions of syringes and coffee capsules, in every second vehicle worldwide, and in energy-related applications.
With around 7,500 employees and 25 production sites on four continents, we work closely with customers from concept to series production. Our employees are at the heart of Datwyler. Guided by Mastery, Impact and Respect, we continuously improve, focus on meaningful results and collaborate with trust and openness.
Become part of our team as a...

Product Inspector

Key Responsibilities

Inspection of End Products

• Inspecting visually with a loupe and microscope, by feeling and using instruments, on finished products in order to achieve production within standard and detect defects (“out of trend” and “out of spec”) early in order to avoid production loss.
• Determining the work sequence in function of the delivery list
• Familiarize yourself with the product type (Pharma / First Line / Alu) and the associated specifications
• Assessing and classifying the defects found according to pre-determined specifications
• Checking the degree of siliconization of the end products and semi-finished products by means of touch (based on experience) and using 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.

Measuring End Products using Instruments

• Measuring end products using various measuring instruments in order to determine whether the
• dimensions of end products are within the standards.
• 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 (MicroVu)

Determining trends based on previous tests and measurements, acquired insights and these report to the QC Manager or designee

Batch Documentation Review

• Checking and assessing the batch documentation for correctness, completeness and conformity with the applicable GMP rules in order to take corrective action if necessary.
• Assess whether all process steps have been carried out and registered as prescribed for the relevant product code;
• Checking retreatment forms in case of re-work: verifying the prescribed actions were executed;
• Checking Line Clearance documents for the different production steps;
• Checking various checklists and forms;
• Report deviations or inadequate data to the QC manager or designee

Assigning the final status to the end products

• Assigning the final status to the end products on the basis of previous tests and checks across the predetermined specifications in order to release or block a batch.
• Filling in various documents: event notification form for reporting out of trends and out of specs, various lists related to the follow-up of the activities
• Granting a final status to the end products: release or blocking (out of trend or out of Spec).

Further Tasks Include

• Control, review, release or block end 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 Final Control team and work in shifts. They are the specialists of the visual and physical inspection of the end product according to company and customer requirements. The QC Lab is outside production, at First Line, however, this lab is located within production and the same rules therefore apply to the wearing of protective clothing. The job holders rotate between labs. 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.

What We’re Looking For

• Knowledge of office software and company-specific software.
• Thorough product knowledge (design, compound, wax code, material and quality knowledge through touch) and knowledge of the production process.
• Thorough knowledge of product defects, specifications, error code and customer-specific requirements.
• Applied knowledge of GMP guidelines and company guidelines including safety.
• Knowledge of English.
• Operating PC, laboratory measuring equipment.
• Concentrated performance of the inspections under loupe and microscope, dimensional and mechanical testing.
• Distinguished, visually, from minor contaminants (from 0.02mm²) and color differences for it recognizing various defects.
• Set up and operate the camera projector to perform routine dimensional measurements.

Be yourself at Datwyler

People make the difference at Datwyler. We offer a wide range of career and development opportunities in an international company where you can contribute your skills, ideas and experience. Together, we create an environment where people can grow and help shape our future.