Technician

POSITION SUMMARY

The Technician (Quality) is responsible for overseeing all quality control activities across molding and assembly operations, conducting in-process control (IPC) laboratory testing, and supervising the end-to-end packing process for medical device products for the 2nd shift. This role ensures that finished goods meet established quality standards, regulatory requirements, and customer specifications. The incumbent is also responsible for label printing operations.

KEY RESPONSIBILITIES

1.  Quality Control – Molding & Assembly

•     Perform and supervise in-process quality inspections at molding and assembly workstations.

•     Verify dimensional, visual, and functional attributes of components and sub-assemblies against approved drawings, specifications, and control plans.

•     Identify and segregate non-conforming materials; initiate NCR (Non-Conformance Reports) and coordinate with production for corrective action.

•     Monitor critical-to-quality (CTQ) parameters during molding operations including shot weight, dimensions, flash, and surface finish.

•     Conduct First Article Inspections (FAI) and First-Off approvals at the start of each production run.

2.  In-Process Control (IPC) Laboratory Testing

•     Perform and oversee IPC laboratory tests including but not limited to:

•     Tensile and pull-force testing

•     Leak and pressure testing

•     Visual inspection

•     Functional testing per applicable test methods

•     Prepare and maintain IPC test samples per sampling plans (AQL-based or otherwise).

•     Interpret test results against acceptance criteria and escalate failures to QA management.

•     Maintain IPC lab cleanliness, records, and SOPs.

3.  Packing Operations Supervision

•     Supervise and coordinate daily packing operations to ensure output meets schedule, quality, and compliance requirements.

•     Verify correct product, quantity, and packaging configuration before packing operations commence (line clearance).

•     Monitor seal integrity, package cleanliness, and labeling accuracy during packing.

•     Conduct final QC checks on packed products including random sampling inspections prior to release.

•     Ensure packing areas are maintained in compliance with cleanroom and GMP requirements.

4.  Label Printing & Verification

•     Operate label printing systems to generate product labels per approved artwork and batch records.

•     Verify label content accuracy including product name, lot number, manufacturing and expiry dates and barcode.

•     Perform label reconciliation at the end of each packing run; investigate and document any discrepancies.

•     Maintain label stock control and ensure obsolete labels are destroyed per document control procedures.

Educational Level

•     Bachelor’s degree or diploma in Engineering / Pharm.D / Sciences

Years of Experience

•     1-2 years of experience in quality control within a medical device, pharmaceutical, or regulated manufacturing environment.

Certifications Required

•     GMP and ISO Certificates

Technical Skills

•     Measurement Tools, Knowledge of ISO standards & GMP, Statistical sampling & SPC

Soft Skills

•     ERP, MS office

Language Requirements

•     English, Kurdish & Arabic