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 12 days ago

Vacancy Summary

Join Hartwig Medical Foundation as a Validation Specialist, where you will enhance cancer care through high-quality genomic diagnostics. Contribute to compliance and quality standards while supporting validation processes across the organization.

Required skills

Verification

Validation

Knowledge base

Analytical Skills

Data

Testing

regulations

Pension

Quality standards

initiative

Life sciences

Training

Quality Management

Workflows

Monitoring

ISO 13485

ISO 15189

Make

Quality Assurance

Procedures

Teams

Presentation

Assessment

SOLID

Technology

Support

CAN

Bachelor's Degree

Culture

Accreditation

Integrity

JOIN

organizational skills

MOST

Document Control

diagnostics

Regulatory Compliance

Profit

ISO 17025

QMS

Motivation

Coordinating

Regulatory Standards

Quality processes

Patient care

treatment

Email

Analyzing

Viewpoint

Your mission is to support Hartwig’s goal of improving cancer care through genomic diagnostics. As a Validation Specialist, you will oversee validation activities, ensuring compliance with regulations and quality standards while aiding colleagues in maintaining efficient processes.

The Role

In this role, you will be pivotal in ensuring our validation processes adhere to the highest quality and regulatory standards. Your daily tasks will include:

•

Developing, implementing, and maintaining validation workflows according to regulations and quality standards.

•

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

•

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

•

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

•

Staying updated with changes in relevant regulations and integrating them into our quality processes.

•

Supporting broader Quality Management System (QMS) activities, including document control and change management.

Requirements

You are a quality professional with a structured and analytical work approach. You value collaboration, communicate with integrity, and understand the significance of high-quality standards in a regulated environment. You can see both the bigger picture and finer details, work effectively across teams, and confidently promote a strong quality culture throughout the organization. Additionally, you have:

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

•

At least 7 years of relevant professional experience.

•

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

•

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

•

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

•

A solid understanding of relevant regulations and quality standards.

•

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

•

A high level of integrity and a commitment to maintaining the highest quality standards.

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