Quality System Specialist
Unilabs is one of Europe’s largest and most comprehensive diagnostic providers, offering an integrated portfolio across laboratory medicine, radiology, pathology, genetics, and specialty testing. The Group performs over 235 million lab tests, 5.5 million imaging exams, and 7.3 million pathology slides annually, supported by more than 12,500 employees and a network of 2,100+ collection centers, 250+ imaging centers, and 200+ laboratories.
We are looking for a Group Quality System Specialist to support the design, deployment, and continuous improvement of our global Quality Management System (QMS). In this role, you will help build a standardized, digitalized, and scalable QMS that strengthens compliance, harmonizes processes across markets, and supports excellent patient and customer outcomes.
You will collaborate with markets, IT teams, and quality leaders to drive process harmonisation, enhance our eQMS, and support training and change management across the organization.
Key Responsibilities
QMS Development & Maintenance
- Support the development and upkeep of Group QMS documentation (policies, processes, SOPs, templates).
- Contribute to process mapping, analysis, and redesign to drive efficiency and compliance.
- Ensure documentation aligns with applicable standards such as ISO 15189, ISO 9001, and GxP (where relevant).
Process Harmonisation & Standardisation
- Assist markets in implementing Group QMS processes and reducing unnecessary variation.
- Support global adoption through training, communication, and ongoing follow-up.
eQMS Administration & Enhancement
- Provide day-to-day support to eQMS users, including troubleshooting, training, and user access management.
- Support configuration changes, module deployment, system upgrades, and validation activities.
- Identify and implement automation opportunities to enhance digital workflows.
- Collaborate with IT, vendors, and market teams to ensure stability and continuous improvement of the system.
Training, Communication & Change Management
- Create training materials, user guides, and learning content for QMS processes.
- Support and deliver training to teams across markets and act as a central point of contact.
Reporting & Quality Metrics
- Develop, track, and analyze KPIs and quality performance metrics.
- Prepare reports and presentations that highlight trends and improvement needs for management.
Requirements
- Bachelor’s or Master’s degree (or equivalent).
- 5–7 years of experience in Quality within the life sciences industry.
- Experience working with global or multisite Quality Management Systems.
- Strong project management capability and high attention to detail.
- Experience providing training and user support for QMS tools.
- Strong analytical and problem-solving skills.
- Ability to collaborate effectively across teams, countries, and functions.
- Knowledge of ISO 9001, ISO 15189, or ISO 13485.
- Expertise in process mapping and quality processes.
- Proficiency in MS Office; experience with QMS systems and Power BI is an advantage.
- Rigorous, organized, autonomous, with excellent communication skills.
- Fluent English (written and spoken).