Data and Implementation Consultant Quality Management Specialist
In short
Job description
About ORTEC Logiqcare
ORTEC Logiqcare empowers healthcare organizations and professionals through data-driven insights, smart digital solutions, and secure, compliant software. As we scale our capabilities in health data science and medical device software, we are looking for a motivated Medical Data Implementation Consultant & Quality Management Specialist to strengthen our team.
This role is ideal for an academically educated professional (PhD or MSc with relevant experience) with a passion for healthcare innovation, and structured quality processes.
About the Role
In this dual position you will spend approximately half of your time on consultancy work within medical and clinical projects and supporting Product Owners, and the other half supporting and managing quality activities for ISO/NEN compliance and MDR requirements.
You will work closely with Product Owners, software developers, and data scientists to support the development and implementation of our medical device software and data management system. Additionally, you will collaborate with also other colleagues with quality related responsibilities and external auditors to ensure that our workflows and software solutions meet the highest standards of quality, security, and regulatory compliance.
What You Will Do
Product Development and Consultancy
- Contribute to medical and biomedical data management across customer and internal projects
- Work in projects to implement the LogiqSuite data management system
- Support development of Software as a Medical Device (SaMD), including documentation and regulatory alignment
- Assist in medical data science activities and implement best practices such as data governance and FAIR principles
- Provide consultancy on data stewardship, metadata standards, and compliant data workflows
Quality Management & Compliance
- 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
- Align with external auditing service providers
- Promote quality awareness across the organization
- Support Product Owners in product MDR compliance (technical documentation, PMS, risk documentation, clinical evaluations, etc.)
- Contribute to ongoing QMS maintenance and improvement and work with the Person Responsible for Regulatory Compliance.
Who are you
Qualifications
- PhD in Medicine, Biomedical Sciences, Life Sciences, Medical or Bio Informatics, Bio Medical Engineering, or similar (MSc with relevant experience also considered)
- Expertise in the area cardiovascular diseases preferred
- Strong interest or experience in data management, data stewardship, and structured documentation
- Familiarity with ISO 27001, NEN 7510, MDR and/or other quality/medical standards
- Able to plan, structure, and prioritize work in a project-based environment
- Self-starter: proactive, autonomous, flexible
- Strong communication skills in English (written & verbal)
- Dutch proficiency preferred
- Living in the Netherlands with a valid NL work permit
- Commutable distance to Zoetermeer
What skills you could bring extra
- Training or coursework in quality management, information security, or medical regulatory frameworks
- Experience supporting audits or working in regulated environments
- Experience with Quality Management Systems (QMS)
- Affinity with software development or SaMD lifecycle documentation
- Knowledge of FAIR, GDPR, and clinical/biomedical data workflows
- Experience in working with data management systems
- Working with data science tools
What we offer
- 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, learning opportunities, and impact on the development of health technology solutions
- The opportunity to contribute to patient health improvements