Senior Validation & Quality Compliance Specialist

Hartwig Medical Foundation; Amsterdam; On-site; EUR 39,000 - 61,000; Full time

Benefits offered by this job

Office lunches Tue/Thu

Friday drinks

Annual team events

Pension plan

26 vacation days

Job summary

Hartwig Medical Foundation is seeking a Validation Specialist to develop and oversee validation activities across the organization. You will ensure compliance with regulations and quality standards while supporting teams in maintaining efficient validation processes.

Responsibilities include implementing validation workflows, reviewing reports, and guiding colleagues in best practices. A strong background in quality management and clinical/diagnostic environments is essential.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• At least 7 years of relevant professional experience.
• Experience with quality management systems and accreditation standards (ISO 17025/15189/13485).
• Experience in accredited clinical or diagnostic environments.

Responsibilities

• Develop, implement and oversee validation workflows compliant with regulations and quality standards.
• Monitor and support verification and validation projects from regulatory and quality perspectives.
• Review and approve verification and validation reports for regulatory and clinical standards.
• Train and support colleagues on established validation workflows, procedures and guidelines.
• Stay updated with changes in regulations and translate into quality processes.
• Support broader Quality Management System activities including document control and change management.

Skills

Quality management

Regulatory understanding

Project coordination

Analytical thinking

Communication

Education

Bachelor's degree in Life Sciences

Job description

Hartwig Medical Foundation is seeking a Validation Specialist to develop and oversee validation activities across the organization. You will ensure compliance with regulations and quality standards while supporting teams in maintaining efficient validation processes.

Responsibilities include implementing validation workflows, reviewing reports, and guiding colleagues in best practices. A strong background in quality management and clinical/diagnostic environments is essential.