Senior ISO 15189 Quality Officer

We are looking for a candidate who possesses:

• HBO or WO working and thinking level.
• At least 5 years of experience as a quality officer within an ISO 15189-accredited laboratory or healthcare environment.
• Demonstrable experience with RvA assessments, Root Cause Analyses, and CAPA management.
• In-depth knowledge of ISO 15189.
• Knowledge of NEN 7510 is a plus.
• Strong analytical, communicative, and advisory skills.
• Persuasiveness, organizational sensitivity, and stakeholder management skills.

We offer a challenging and impactful position within an innovative diagnostic organization where quality is central.

In addition, we offer:

• A position for 32-40 hours per week
• Salary range between € 4300 and € 7000 gross per month based on 40h. 
• Good secondary employment conditions.
• A professional environment in which you are given plenty of room for your own initiative.
• Participation in organization-wide improvement and innovation projects.
• Opportunities for personal development and further specialization.

At Clinical Diagnostics Nederland, we are driven by our mission to contribute to a healthy and safe world for everyone. With a network of leading laboratories, we offer a complete diagnostic portfolio, including clinical chemistry, medical microbiology, pathology, molecular diagnostics, genomics, and functional and imaging studies.

Within our organization, quality plays a crucial role. To further strengthen our quality team, we are looking for an experienced Senior ISO 15189 Quality Officer who wants to fulfill a key role in safeguarding and further developing our quality management system.

Are you an experienced quality professional with in-depth knowledge of ISO 15189? Do you get energy from guiding accreditations, audits, and organization-wide improvement processes? Are you able to advise management, laboratories, and other stakeholders and involve them in quality improvements? Then we are looking for you!

As Senior ISO 15189 Quality Officer, you are responsible for the independent development, implementation, maintenance, and improvement of the quality management system within the organization. You are the subject matter expert in the field of quality management and accreditation requirements.

Your duties include:

• Advising management and process owners on quality issues and quality policy.
• Monitoring compliance with ISO 15189, ISO 9001, relevant laws and regulations, and preferably NEN 7510.
• Drafting and executing internal audit programs and guiding external audits and accreditation assessments.
• Performing complex Root Cause Analyses (RCAs) and guiding CAPA processes.
• Assessing deviations, complaints, and incidents and initiating corrective and preventive measures.
• Performing risk and impact analyses and advising on quality and compliance risks.
• Initiating and guiding organization-wide improvement projects.
• Providing training, guidance, and knowledge transfer in the field of quality management and accreditation requirements.
• Maintaining contacts with the Dutch Accreditation Council (RvA), external auditors, and internal stakeholders.

Your primary location is Rijswijk. Additionally, you are willing to perform work at other locations, including Leiden.