Validation Specialist at Hartwig Medical Foundation

H

Validation Specialist

Hartwig Medical Foundation

Amsterdam, North Holland, Netherlands

3.500 – 5.500 / month

On-Site

Expert

posted 75 days ago

View company profile

Vacancy Summary

Join Hartwig Medical Foundation as a Validation Specialist and play a crucial role in enhancing cancer care through high-quality genomic diagnostics. You will oversee validation activities, ensuring compliance with regulations and quality standards while supporting a collaborative team environment.

Required skills

Patient care

Reliability

English level

Professional

Would you like to contribute to Hartwig’s mission to improve care for patients with cancer? At Hartwig Medical Foundation, we are dedicated to enhancing cancer care through high-quality genomic diagnostics and data. Quality, reliability, and compliance are at the core of our operations. To strengthen our Quality team, we are looking for an experienced Validation Specialist.

De Rol

As our Validation Specialist, you will be instrumental in ensuring that our validation processes adhere to the highest quality and regulatory standards. Your responsibilities will include:

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Developing, implementing, and maintaining validation workflows in accordance with applicable regulations and quality standards.

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Monitoring and supporting verification and validation projects from a regulatory and quality perspective.

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Reviewing and approving verification and validation reports to ensure compliance with regulatory requirements and clinical standards.

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Training and supporting colleagues involved in verification and validation activities on established workflows, procedures, and guidelines.

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Keeping up to date with changes in relevant regulations and translating these into our quality processes.

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Supporting broader Quality Management System (QMS) activities, including document control, change management, and other quality-related processes.

Vereisten

You are a quality professional with a structured and analytical approach to your work. You enjoy collaborating with others, communicate with integrity, and understand the importance of maintaining high-quality standards in a regulated environment. You can see both the bigger picture and the finer details, work effectively across teams, and confidently promote a strong quality culture throughout the organization. In addition, you have:

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A Bachelor's degree in Life Sciences or a related field.

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At least 7 years of relevant professional experience.

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Experience working with quality management systems and accreditation standards, preferably ISO 17025, ISO 15189, and/or ISO 13485.

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Experience working in an accredited environment, ideally within a clinical or diagnostic setting.

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Proven experience in designing, executing, and coordinating validation projects.

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A solid understanding of, or the ability to quickly acquire knowledge of, relevant regulations and quality standards.

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Excellent organizational skills, with the ability to effectively prioritize work and manage multiple projects simultaneously.

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A high level of integrity, a strong sense of responsibility, and a commitment to maintaining the highest quality standards.

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