Jobs / other
Validation Specialist
Hartwig Medical · Amsterdam
Salary shownIND sponsor
What you will do
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.
What they look for
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 are able to 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:
- 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.