QMS Expert - Medical Laboratory Accreditation (ISO/IEC 15189)

Job description

TRACE Consulting is a Bangladesh-based strategic advisory and consulting firm working across international trade, trade facilitation, economic and regulatory policy reform, digital transformation, laboratory improvement, institutional capacity building, and international development. The QMS Expert will support technical assistance and quality management system (QMS) implementation for medical diagnostic facilities seeking ISO/IEC 15189:2022 accreditation. The person will play a central role in conducting gap assessments, developing clinical QMS documentation, executing hands-on technical training, and facilitating formal accreditation through the Bangladesh Accreditation Board (BAB). This is a full-time position based in Dhaka, Bangladesh, on a short-term (3 months) basis. Candidates with a proven track record of securing national or international laboratory accreditations will have an advantage. Send applications to contact@traceconsultingltd.com or via the website.

Responsibilities

• Develop, implement, and optimize Quality Management Systems (QMS) and SOPs for diagnostic facilities in strict alignment with ISO/IEC 15189:2022 and patient-centered risk management guidelines.
• Conduct comprehensive baseline gap assessments covering the full diagnostic cycle (pre-examination, examination, and post-examination) and define corrective action roadmaps for management review.
• Formulate comprehensive QMS documentation, including quality manuals, patient privacy agreements, mandatory procedures, technical SOPs, and governance protocols for Point-of-Care Testing (POCT).
• Drive clinical quality control implementation by establishing Internal Quality Control (IQC) rules, calculating Measurement Uncertainty (MU), and managing External Quality Assurance (EQA) and proficiency testing participation.
• Execute patient-focused risk assessments (aligning with ISO 22367) and facilitate training for technical staff on competency criteria, method verification, and clinical Root Cause Analysis (RCA).
• Lead comprehensive mock internal audits across all laboratory departments and provide on-site accompaniment support during BAB pre-assessments and final audits to ensure the timely closure of all non-conformities.

Requirements

• Master's degree in biochemistry, pharmacy, clinical pathology, microbiology, or a closely related scientific discipline.
• A minimum of 3-5 years of progressive experience in clinical laboratory operations, QMS implementation, and quality assurance.
• Demonstrated hands-on experience successfully securing or managing ISO/IEC 15189 accreditation for medical diagnostic centers.
• Deep technical understanding of clinical method verification, IQC rules (e.g., Westgard), metrological traceability, and medical laboratory safety (ISO 15190).
• Strong analytical and problem-solving skills with the ability to conduct rigorous internal audits and guide teams through complex root cause analyses.
• Outstanding interpersonal and relationship-building capabilities to effectively train laboratory personnel and present strategic roadmaps to top management.
• Exceptional communication and presentation skills (verbal and written) in both English and Bengali.

Skills

• Internal Audit
• ISO/IEC 15189
• Method Verification
• Quality Management Systems
• Root Cause Analysis