Quality Controller

Zhende Middle East; Jeddah; On-site; SAR 150,000 - 190,000; Full time

Job summary

Zhende Middle East is seeking a Quality Inspector to conduct in-process and final inspections of medical devices to verify conformance with specifications.

You will document results, support CAPA investigations, and ensure compliance with ISO 13485, GMP and QA procedures in a manufacturing environment in Saudi Arabia. Strong English communication and attention to detail are essential. Experience in regulated industries is preferred.

Qualifications

• Bachelor’s degree or diploma in Quality Management, Medical Devices, Biomedical Engineering, Mechanical Engineering, Industrial Engineering, Chemistry or related field.
• Experience in quality control or inspection, preferably in medical device or regulated manufacturing industries.
• Knowledge of ISO 13485, GMP, QA systems and non-conforming product control is highly preferred.
• Good problem-solving and documentation skills, ability to work independently.
• Strong English communication and teamwork abilities.

Responsibilities

• Perform incoming in-process and final quality inspections of raw materials, components, semi-finished products and finished medical device products according to approved specifications.
• Conduct routine quality inspections and testing during manufacturing to ensure products meet quality standards.
• Verify product dimensions, appearance, functionality, packaging, labeling and other quality requirements.
• Identify, report and document quality defects, deviations and non-conformities in a timely manner.
• Isolate non-conforming materials or products and follow procedures for non-conforming product control.
• Maintain accurate QC inspection records, test results and checklists.
• Support investigation and CAPA activities to address quality issues.
• Ensure QC activities comply with ISO 13485, GMP, and company QA procedures.
• Follow document control, traceability and product quality management requirements.
• Perform other quality-related duties as assigned by QC Supervisor or Quality Manager.

Skills

Attention to detail

Documentation

CAPA

Analytical thinking

Teamwork / collaboration

English communication

Education

Bachelor's degree or diploma in Quality/Medical Devices/Engineering

Tools

MS Office

GMP/QA documentation systems

Job description

Job Responsibilities

• Perform incoming in-process and final quality inspections of raw materials components semi-finished products and finished medical device products according to approved specifications and inspection procedures
• Conduct routine quality inspections and testing during the manufacturing process to ensure products meet established quality standards and specifications
• Verify product dimensions appearance functionality packaging labeling and other applicable quality requirements
• Identify record and report quality defects deviations and non-conformities in a timely manner
• Isolate and properly identify non-conforming materials or products and follow the established procedures for non-conforming product control
• Maintain accurate and complete QC inspection records test results checklists and other quality-related documentation
• Support investigation and analysis of quality issues and assist in implementing corrective and preventive actions CAPA
• Ensure all quality control activities comply with company procedures applicable Saudi regulations and relevant medical device quality management system requirements
• Follow company requirements related to ISO 13485 GMP document control traceability and product quality management
• Perform other quality-related duties assigned by the QC Supervisor or Quality Manager

Requirements & Qualifications

• Bachelor’s degree or diploma in Quality Management, Medical Devices, Biomedical Engineering, Mechanical Engineering, Industrial Engineering, Chemistry, Biology, or a related field.
• Previous experience in quality control or quality inspection, preferably in medical device, pharmaceutical, healthcare, or other regulated manufacturing industries.
• Knowledge of medical device quality control processes and inspection methods is preferred.
• Familiarity with ISO 13485, GMP, quality management systems, and non-conforming product control is highly preferred.
• Good understanding of basic quality tools and methods, such as inspection plans, sampling, defect classification, root cause analysis, and CAPA.
• Good problem-solving and analytical skills.
• Good documentation and record-keeping skills.
• Ability to work independently and effectively in a manufacturing environment.
• Good communication and teamwork skills.
• Good command of English, both written and spoken.
• Basic computer skills, including Microsoft Office (Word, Excel, Outlook).