· Demonstrates and promotes the company vision and policy.· Develops, implements and monitors Unilabs NL's quality management system in line with Unilabs Group policy and on the basis of applicable laws and regulations, ISO standards, applicable standards from customers. The manager can be expected to ensure that the quality policy is based on the latest insights and challenges. To this end, close contacts and cooperation are maintained with the relevant Group and national leaders and experts.· Translates Unilabs Group's quality policy into a tactically and operationally feasible work process and its uniform and consistent implementation throughout the company.· Promotes a culture of quality by educating others in quality management system fundamentals, programs and tools.· Ensures non-conformances, adverse events and complaints are identified and documented and that timeliness requirements are met. Assess risk, assists in root cause analysis and corrective action efforts. Monitors trends and create reports for periodic quality meeting and management review.· Prepare quality meeting data/presentation.· Conducts Quality Management Review meeting at least once per year in cooperation with laboratory management and Country Leadership Team.· Plan and take part in internal audits. Follow-up of actions following audits.· Participates in the preparation of accreditation dossiers, accompany auditors (e.g. ISO quality inspectors) during audits of the laboratories and coordinates responses to audit findings.· Ensures regulatory compliance of all laboratories by maintaining up-to-date knowledge of requirements and coordinating activities to fulfill requirements.· Ensures continuous improvement: indicators and dashboards, implementation and monitoring of preventive and corrective actions.· Communicate the results of evaluating the effectiveness of the Quality Management System, as well as reporting other area management information (performance indicators) and any need for improvement, to hierarchical superiors, both at local and Group level, with a view to providing information to support decision-making.· Coordinates the implementation of the European In-Vitro Diagnostic Regulation in all laboratories, ensuring the compliance of the in-house devices with the Art 5(5) of the European In-Vitro Diagnostic Regulation (IVDR).· Monitors in collaboration with procurement team the compliance readiness of suppliers of commercial CE-IVD devices with IVDR.· Ensures appropriate implementation of the risk management procedure in all laboratories.· Represents Quality and Regulatory function in the due diligence assessment done as part of the M&A Process and in the integration process for newly acquired companies.· Performs other duties as assigned.Leadership· Sets the overall direction for the standardization and harmonization of quality related processes considering the Group quality strategy and the big picture of internal and external aspects· Identifies and drives changes in a future-oriented, solution-oriented and proactive manner· Creates an open-minded atmosphere to allow innovative thinking by encouraging others to express their individual point of view, listens carefully to extract business potentials.Organization· Reporting line: Head Quality and Regulatory Affairs· Location: Amsterdam· Full time positionRequirements· Bachelor’s degree or master’s degree in a technical/ process engineering/QA discipline, with significant related professional experience within the laboratory environment.· Prior in-depth and hands-on experience working in an ISO 15189 accredited testing laboratory and with a focus on Quality Management Systems.· Ideally experience with medical device regulation and/or in-vitro diagnostic directive regulation· Demonstrated ability to affect change.· Excellent interpersonal, organizational & communication skills with excellent attention to detail.· Self-motivated and driven critical thinker able to work in high pace and rapidly changing environment.· Responsive problem solver and action oriented.· English and Dutch fluent are a must (presenting, writing, reading).· Minimum Years Recommended and/or Preferred: 15 years
