Global Quality Engineer

Global Quality Engineer

As a Global Quality Engineer, you will lead quality improvement projects across multiple sites and support our healthcare teams in implementing quality initiatives.

Key responsibilities include analyzing data to enhance product quality and ensuring compliance with regulatory standards for medical devices and software.

Main responsibilities:

• Lead and manage quality improvement projects across various production and design sites.
• Analyze quality data to improve product quality and regulatory compliance.
• Collaborate with cross-functional teams to develop data-driven solutions.
• Monitor KPIs related to product quality, software reliability, and processes.
• Develop dashboards and reports to communicate quality insights.
• Conduct statistical analysis to drive continuous improvements (e.g., Six Sigma, SPC).
• Manage CAPA processes, including root cause analysis and corrective actions.
• Ensure compliance with industry standards (e.g., FDA, ISO 13485, MDR).
• Provide training on quality analytics tools and participate in audits.

Requirements:

• Master's degree in Engineering, Data Science, Biomedical Engineering, or related field.
• 3+ years of experience in quality engineering or analytics, preferably in medical devices or software.
• Proficiency in data analysis tools (e.g., SQL, Python, Excel, Power BI).
• Strong knowledge of statistical methods and quality assurance in medical devices.
• Excellent problem-solving, communication, and teamwork skills.
• Familiarity with industry regulations (e.g., FDA, ISO 13485, ISO 62304, MDR).