Data and Implementation Consultant Quality Management Specialist

Responsibilities

• Contribute to medical and biomedical data management across customer and internal projects
• Support the development of Software as a Medical Device (SaMD), including documentation and regulatory alignment
• Implement best practices such as data governance and FAIR principles
• Coordinate quality-related activities for ISO 27001, NEN 7510, and MDR
• Prepare and support internal and external audits
• Process and follow up on non-conformities and improvement actions
• Support Product Owners in MDR compliance, including technical documentation, risk documentation, and clinical evaluations

Requirements

• PhD in Medicine, Biomedical Sciences, Life Sciences, Medical/Bio Informatics, or Bio Medical Engineering (MSc with relevant experience also considered)
• Familiarity with ISO 27001, NEN 7510, MDR, and/or other quality/medical standards
• Strong communication skills in English (written and verbal)
• Valid NL work permit and ability to commute to Zoetermeer
• Ability to plan, structure, and prioritize work in a project-based environment

Preferred Qualifications

• Expertise in the area of cardiovascular diseases
• Training or coursework in quality management, information security, or medical regulatory frameworks
• Experience working with Quality Management Systems (QMS) or supporting audits in regulated environments
• Knowledge of FAIR, GDPR, and clinical/biomedical data workflows
• Proficiency in Dutch
• Experience with data science tools or data management systems

Benefits

• A meaningful role in advancing data-driven healthcare
• Room to grow in both consultancy and regulatory quality domains
• A collaborative team environment committed to continuous improvement
• Flexibility and learning opportunities within health technology solutions

About the Company

ORTEC Logiqcare empowers healthcare organizations and professionals through data-driven insights, smart digital solutions, and secure, compliant software. As part of ORTEC, a global leader in optimization software and analytics, we focus on turning complex healthcare challenges into easy-to-use, impactful solutions.