Quality Engineer (Global)

Main accountabilities

The Quality Engineer will focus on project management and driving continuous improvement:

• Lead Quality improvement project that are set up across sites.
• Suporting the Healthcare Quality teams on implementation of quality projects in the different production and design sites
• Analyzing quality data to drive improvements in product quality and compliance with regulatory standards for both medical grade ITE, Medical devices and software.
• Work closely with cross-functional teams to identify trends, develop insights, and implement data-driven solutions to enhance overall quality.

Tasks

• Monitor key performance indicators (KPIs) related to product quality, software reliability and quality processes.
• Develop and maintain dashboards, reports, and visualizations to communicate quality metrics and insights to stakeholders.
• Collect, analyze, and interpret quality data from various sources (e.g., production data, customer feedback, field data, software performance data) to identify trends, patterns, and areas for improvement.  Conduct statistical analysis and apply quality management tools (e.g., Six Sigma, SPC) to drive continuous improvement initiatives.
• Project management for improvement projects and specific Quality projects accross sites and functions
• Drive governance on CAPA process : root cause analysis and corrective action efforts based on data findings to address quality issues.
• Collaborate with engineering, production, and quality teams to develop and implement data-driven process improvements.
• Support compliance with industry standards and regulations (e.g., FDA, ISO 13485, ISO 62304, MDR) through data analysis and reporting.
• Provide training and support to staff on quality analytics tools and best practices.
• Participate in internal and external quality audits, focusing on data integrity and accuracy.
• Stay current with industry trends, advancements, and best practices in quality analytics and data science within the medical device and software sectors.

Required competencies

• Master  degree in (Quality) Engineering, Data Science, Statistics, Biomedical Engineering, Software Engineering, or a related field.
• Minimum of 3 years of experience in quality engineering or quality analytics within the medical device and/or medical software industry.
• Proficiency in data analysis tools and visualizationsoftware (e.g., SQL, Python, Excel, Power BI ...).
• Strong knowledge of statistical methods and quality assurance methodologies specific to medical devices and software.
• Excellent problem-solving & root cause analysis skills and attention to detail.
• Strong communication and interpersonal skills.
• Ability to work effectively in a team environment and independently.
• Familiarity with medical device and software industry standards and regulations (e.g., FDA 21 CFR Part 820, ISO 13485, ISO 62304, MDR) is preferred.

D&I Statement

At Barco, innovation drives everything we do. We believe that diversity fuels creativity, bringing us closer to our colleagues and customers. Inclusion and equity aren't just values—they're core capabilities that propel us toward our shared goals and mission.

Read here how we do this