The Test Lab Quality Executive supports the Quality Manager in implementing, maintaining, and continually improving the Laboratory Quality Management System (LQMS) in line with ISO/IEC 17025 and the Accreditation Body requirements. The role coordinates the lab’s quality activities, including document control, audits, non-conformities, customer feedback, proficiency testing, equipment traceability, and quality records. The goal is to keep test results valid and reliable and the laboratory ready for assessment.
The position reports to the Quality Manager.
KEY RESPONSIBILITIES
- LQMS Implementation & Documentation
- Assist the QM in monitoring the laboratory’s compliance with ISO/IEC 17025, accreditation body-specific requirements, and LQMS, and highlight gaps or risks to the system.
- Control LQMS documents, including Quality Manual, procedures, work instructions, forms, and test methods. This covers issuance, revision, distribution, withdrawal of obsolete versions and the master list.
- Make sure only current, approved versions of documents and external standards are in use at all workstations.
- Maintain quality records in an organised, retrievable and secure way, following the record retention schedule, prepare records due for disposal for QM approval.
- Audits, Non-Conformities & Improvement
- Plan, coordinate, and conduct internal audits according to the annual audit program, and prepare audit reports.
- Coordinate external audits and AB assessments (initial, surveillance, reassessment and scope extension), including preparing evidence and arranging logistics.
- Register and track non-conforming work, audit findings and corrective actions. Facilitate root cause analysis and verify that corrective actions are effective before closing them.
- Maintain the register of risks and opportunities and monitor whether the planned actions are carried out.
- Compile data and prepare the agenda, inputs and minutes for the management review, and follow up on the actions that come out of it.
- Customer Feedback & Complaints
- Log, acknowledge, and track customer complaints and feedback, and coordinate investigations with the relevant sections.
- Carry out customer satisfaction surveys periodically and analyse the results for improvement opportunities.
- Assuring the Validity of Results
- Coordinate participation in proficiency testing (PT) and interlaboratory comparisons (ILC), monitor performance (e.g z-scores) and start investigations when results are unsatisfactory.
- Monitor internal quality control activities such as replicate test, reference materials, control charts, and intermediate checks and report trends to the QM.
- Support method verification and validation activities and the evaluation of measurement uncertainty; keep the related records.
- Equipment, Traceability & Suppliers
- Maintain the equipment register and the calibration and maintenance schedule, and review calibration certificates to confirm metrological traceability and acceptance criteria are met.
- Support the evaluation and monitoring of external providers, such as calibration labs, PT providers, reference material suppliers, and subcontracted laboratories.
- Training & Competency
- Assist in identifying training needs (TNA) and coordinate the annual training plan.
- Maintain personnel records, including qualifications, training competency assessments, authorizations and ongoing competency monitoring.
- Impartiality, Confidentiality & Communication
- Comply with and promote the laboratory’s impartiality and confidentiality requirements, and maintain signed undertakings and impartiality risk assessments.
- Act as the QM’s point of contact for AB correspondence and coordinate with external parties when QM delegates this.
- Prepare quality KPI reports (e.g. NCR closure rate, complaints trends, PT performance, audit status) for the QM and Laboratory Head.
- Perform other quality-related duties assigned by the QM.
- Continuous Improvement and Reporting
- Identify and recommend opportunities to improve the effectiveness and efficiency of LQMS.
- Prepare periodic quality performance reports for the QM and Top Management.
- Monitor the status of quality objectives, audit findings, corrective actions, complaints and improvement initiatives.
- Maintain a quality action tracker and follow up on outstanding actions.
- Use audit results, data analysis, feedback and risk assessments to support evidence-based improvement.
QUALIFICATIONS
Diploma or Bachelor’s Degree in Chemistry, Applied Science, Engineering (Electrical, Mechanical, Chemical, or Materials), Quality Management, or a Related Field.
EXPERIENCE
- Formal training in ISO/IEC 17025:2017 requirements.
- An ISO/IEC 17025 Internal Auditor certificate (or willingness to obtain one within the probation period).
- At least 2 years of experience in a testing or calibration laboratory operating under ISO/IEC 17025, preferably in a quality assurance or quality system role. Degree holders with 1 year of relevant quality experience may be considered.
SKILLSETS
- Sound understanding of ISO/IEC 17025:2017 and AB accreditation requirements and policies.
- Good document control and record management skills, with strong attention to detail.
- Ability to conduct internal audits and write objective, clear audit reports.
- Knowledge of root cause analysis and corrective action tools (e.g. 5 Whys, fishbone diagram, CAPA).
- Basic statistics for quality control and PT evaluation (mean, standard deviation, z-score, control charts).
- Proficiency in Microsoft Office, especially Excel and Word.
- Good written and verbal communication in English and Bahasa Malaysia.
- Organized, able to manage multiple deadlines, and able to work with all level of laboratory staff.
OPTIONAL SKILLSETS
- Hands-on experience as a test lab analyst or technician.
- Knowledge of measurement uncertainty estimation and method validation.
- Familiarity with ISO 9001, ISO/IEC 17043 (PT)
- Advanced Excel or data visualization tools (e.g. Power BI) for quality KPI reporting.
- Experience in metrology or equipment calibration.