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Group Quality System Specialist

UnilabsPorto, Porto District, Portugal
On-site Full-time

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Experience Level

Mid to Senior

Qualifications

Requirements:Bachelor’s or Master’s degree (or equivalent).5–7 years of experience in Quality within the life sciences industry. Proven experience working with QMS standards and regulations. Familiarity with ISO 15189, ISO 9001, and GxP regulations. Excellent communication and interpersonal skills. Strong analytical and problem-solving capabilities. Ability to work collaboratively in a cross-functional team environment.

About the job

Unilabs stands as one of Europe's foremost diagnostic providers, delivering a comprehensive suite of services in laboratory medicine, radiology, pathology, genetics, and specialty testing. Each year, our dedicated team conducts over 235 million lab tests, 5.5 million imaging exams, and analyzes 7.3 million pathology slides, all supported by a workforce of more than 12,500 employees and a vast network of over 2,100 collection centers, 250 imaging centers, and 200 laboratories.

We are seeking a Group Quality System Specialist to assist in the design, implementation, and ongoing enhancement of our global Quality Management System (QMS). In this pivotal role, you will contribute to the development of a standardized, digitized, and scalable QMS that enhances compliance, streamlines processes across various markets, and bolsters exceptional patient and customer outcomes.

Your collaboration with market teams, IT departments, and quality leaders will be instrumental in driving process harmonization, refining our electronic Quality Management System (eQMS), and facilitating training and change management initiatives across the organization.

Key Responsibilities:

  • QMS Development & Maintenance: Aid in the creation and maintenance of Group QMS documentation, including policies, processes, SOPs, and templates. Participate in process mapping, analysis, and redesign to enhance efficiency and compliance. Ensure all documentation meets applicable standards such as ISO 15189, ISO 9001, and GxP where relevant.
  • Process Harmonisation & Standardisation: Support markets in implementing Group QMS processes and minimizing unnecessary variations. Promote global adoption through effective training, communication, and ongoing support.
  • eQMS Administration & Enhancement: Provide daily support to eQMS users, including troubleshooting, training, and managing user access. Assist with configuration changes, module deployment, system upgrades, and validation activities. Discover and implement automation opportunities to optimize digital workflows. Collaborate with IT, vendors, and market teams to ensure system stability and continuous improvement.
  • Training, Communication & Change Management: Develop training materials, user guides, and learning content for QMS processes. Deliver training sessions to teams across markets and serve as a central contact point.
  • Reporting & Quality Metrics: Create, track, and analyze KPIs and quality performance metrics. Prepare reports and presentations to highlight trends and areas for improvement for management review.

About Unilabs

Unilabs is a leading diagnostic service provider in Europe, renowned for its wide-ranging and integrated diagnostic solutions. With millions of tests performed annually, Unilabs is committed to delivering high-quality services that enhance patient care and support healthcare professionals across various fields.

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