Senior Kwaliteitsfunctionaris ISO 15189

Role Summary

Are you an experienced quality professional with in-depth knowledge of ISO 15189? Do you get energy from supervising 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!

Activities

As a Senior Quality Officer ISO 15189 you are responsible for independently developing, implementing, maintaining and improving the quality management system within the organization. You are the substantive expert in the field of quality management and accreditation requirements.

Interested?

Do you want to be part of our organization and contribute to high-quality laboratory processes?

Then apply via the application button!

Responsibilities

Your duties include

• Advising management and process owners on quality issues and quality policy.
• Monitoring compliance with ISO 15189, ISO 9001, relevant legislation and regulations and preferably NEN 7510.
• Drawing up and implementing internal audit programs and supervising external audits and accreditation assessments.
• Carrying out complex Root Cause Analyzes (RCAs) and supervising CAPA processes.
• Assessing deviations, complaints and incidents and initiating corrective and preventive measures.
• Carrying out risk and impact analyzes and advising on quality and compliance risks.

Initiating and supervising organization-wide improvement projects

• Providing training, guidance and knowledge transfer in the field of quality management and accreditation requirements.
• Maintaining contacts with the Accreditation Council, external auditors and internal stakeholders

Requirements

• We are looking for a candidate who has
• 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 Analyzes and CAPA management.
• In-depth knowledge of ISO 15189.
• Knowledge of NEN 7510 is an advantage.
• Strong analytical, communication and advisory skills.
• Persuasiveness, organizational sensitivity and stakeholder management skills.
• In addition, we offer

A position for 32-40 hours per week

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

Benefits

• We offer a challenging and impactful position within an innovative diagnostic organization where quality is central.
• Your location is mainly Rijswijk. In addition, you are willing to carry out work at other locations, including Leiden.

About the Company

About Clinical Diagnostics Netherlands

At Clinical Diagnostics Netherlands 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 research.

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