Validation Specialist

As our Validation Specialist, you will play a key role in ensuring that our validation processes meet the highest quality and regulatory standards. Your responsibilities will include:

• Developing, implementing and maintaining validation workflows in accordance with applicable regulations and quality standards.
• Monitoring and supporting verification and validation projects from a regulatory and quality perspective.
• Reviewing and approving verification and validation reports to ensure compliance with regulatory requirements and clinical standards.
• Training and supporting colleagues involved in verification and validation activities on established workflows, procedures and guidelines.
• Keeping up to date with changes in relevant regulations and translating these into our quality processes.
• Supporting broader Quality Management System (QMS) activities, including document control, change management and other quality-related processes.

In addition, you have:

• A Bachelor's degree in Life Sciences or a related field.
• At least 7 years of relevant professional experience.
• Experience working with quality management systems and accreditation standards, preferably ISO 17025, ISO 15189 and/or ISO 13485.
• Experience working in an accredited environment, ideally within a clinical or diagnostic setting.
• Proven experience in designing, executing and coordinating validation projects.
• A solid understanding of, or the ability to quickly acquire knowledge of, relevant regulations and quality standards.
• Excellent organizational skills, with the ability to effectively prioritize work and manage multiple projects simultaneously.
• A high level of integrity, a strong sense of responsibility and a commitment to maintaining the highest quality standards.

• A meaningful position (32–40 hours per week) within a mission-driven, non-profit organization.
• The opportunity to work at the intersection of life sciences, data and technology in a rapidly evolving field.
• A collaborative, open and informal working environment where knowledge sharing and initiative are encouraged.
• A monthly salary between EUR 3,500 and EUR 5,500 gross, based on experience and skills.
• 26 vacation days (based on full-time employment).
• A pension plan to which Hartwig Medical Foundation contributes two-thirds of the premium.
• Complimentary office lunches on Tuesdays and Thursdays, Friday afternoon drinks, and annual team events.