Key Skills

Job Description

About the Company An international organization operating in the healthcare industry, focused on maintaining high standards of product quality, manufacturing compliance and patient safety. Role Description As a Quality Engineer, you will provide quality systems and compliance support across manufacturing operations and external manufacturing partners. You will oversee quality performance, audits and process improvement activities, while addressing complex product and manufacturing issues and ensuring compliance with applicable quality standards. Key Responsibilities Support the design, implementation and maintenance of quality systems and manufacturing processes. Assess compliance with GMP, ISO standards and Equipment Engineering Systems (EES) requirements. Oversee quality system audits and identify areas requiring corrective action or improvement. Investigate and resolve product and process complaints, defects and quality issues. Monitor contract manufacturer performance through quality metrics and management reviews. Establish and maintain measurement systems to evaluate quality and reliability performance. Identify, contain, correct and prevent product and process defects. Prepare and present quality performance reports and improvement recommendations to management. Provide technical quality support for complex manufacturing processes being transferred to other facilities. Requirements Experience in Quality Engineering or Quality Systems within a GMP manufacturing environment. Strong knowledge of GMP, ISO standards and manufacturing quality systems. Experience with quality audits, compliance assessments and process improvement. Knowledge of complaint handling, defect investigation and corrective and preventive actions (CAPA). Experience monitoring supplier or contract manufacturer quality performance. Ability to analyse quality metrics and translate findings into improvement actions. Strong technical problem-solving and analytical skills. Experience supporting manufacturing processes and/or technology transfers is advantageous.

Core Responsibilities

Support and maintain quality systems and manufacturing processes, assess compliance, conduct audits, and investigate product or process issues. Monitor external manufacturing partners, analyze quality performance, recommend improvements, and provide technical support for complex manufacturing processes and transfers.

Requirements

Experience in quality engineering or quality systems in a GMP manufacturing environment, with strong knowledge of GMP, ISO standards, audits, compliance, and process improvement. The role also requires experience with complaint and defect investigations, CAPA, supplier or contract manufacturer performance, and quality metrics; manufacturing or technology transfer experience is advantageous.