Job Description

This designation is responsible in ensuring that processes needed for the quality management system are established, implemented, and maintained. The Quality Manager reports to the Head of Quality- Netherlands and collaborates with the laboratory management when decisions are to be made with regards to laboratory policy, objectives, resources, and opportunities for improvement. Task involves technical and administrative duties across the different departments. This designation promotes awareness of the quality management system requirements throughout the laboratory organization

Responsibilities

• Manage the execution of the global quality program within their region in cooperation with the leads reporting to them at both partner and internal sites. Responsible for driving regional performance through quality initiatives.
• Promote quality achievement and performance improvement throughout the organization
• Ability to create general policies and Quality policies as per international and local standards (CAP, ISO-15189, DOH).
• Assist Lab Professionals towards achievements of international accreditation of CAP, ISO-15189 and other Local regulation requirements.
• Help Supervise all Quality practices and support end-users to ensure high quality lab services in Unilabs Middle East facilities
• Develop, implement safety program and emergency response plan. Provide training on, the laboratories’ Safety Policy, Environment, and Quality System Essentials to all laboratory staff.
• Lead Quality meetings to review the performance of the laboratories and identify opportunities for improvement.
• Improve quality, operational excellence and innovation in laboratory services in accordance with international standards, best practices and benchmarking. Ability to drive improvement projects with proven results, and to deliver and report on robust Quality initiatives with clear priorities and objectives for the future.
• Support and conduct quality management audits and review its effectiveness
• Track and trend data regarding customer satisfaction, non-conformances, inspection findings, customer satisfaction feedback, risk assessment to develop strategies, continuous improvement and reduce complaint incidences.
• Execute Quality Improvement process in effective communication, auditing and inspections through participating in Quality improvement projects for Laboratories (local and international accreditation) monitoring their KPIs, statistics, operational plans and proficiency testing reviews.
• Establish and maintain a sustainable quality management system and evaluate its effectiveness through implementation of a structured audit process.
• Provide leadership and guidance to the QA team members and other relevant teams. Responsible for managing the Quality Assurance Department the day-to-day laboratory QA operations and activities of all the Quality Systems
• Performs duties as assigned or requested by the Head of Quality-Netherlands.
• Produces and analyses reports on quality performance measured against indicators in addition to collaboration with other departments to identify new indicators.
• Work with operations team to oversee completion of test and procedure verifications. Review if the process verification, conforms with the standard requirements as specified by local and international accrediting agencies or standards of practice. Raise any concerns or deviation to further assess prior to test go live.
• Develop, review, and manage the development and implementation of Quality policies, objectives, procedures, work instructions etc.
• Oversee document management systems is in place and controlled to ensure it is up to date and distributed to relevant staff. Ensure that relevant document meets with the regulatory and accrediting agencies.
• Work with cross-functional team to investigate non-conformances, incidents, opportunities for improvement and develop strategies for continuous improvement. Ensure that plans are implemented and effective.
• Provide training on non-conformance management to include root cause analysis, corrective action, and continuous improvement.
• Generate and analyse key performance indicators and work with relevant teams on investigation, process improvement, and identify new metrics.

Qualifications

• Master’s degree in quality management and minimum 8 years’ experience in quality assurance within a healthcare or diagnostic industry.
• Certifications in one or more for ISO, OHSAS, CPHQ and Auditing Quality Management system in healthcare.
• BSc in Medical Technology with appropriate clinical internship/ Laboratory Technology or Biomedical Science
• Experience with International and local Accreditations like ISO 15189 and ISO 9001, CAP, JCI, DHA, MOH, DOH, etc.
• Experience in the laboratory diagnosis of infectious diseases including specific hands-on laboratory experience.
• Demonstrated proficiency in Quality Assurance, Quality Control and SOP writing.
• Experience in accreditations, inspections and regulations related to the field.
• Excellent verbal and written communication skills and a demonstrated competency to interact with people at all levels of the organization.
• Highly developed organizational, analytical and problem-solving skills are required