Quality Engineer (Qms)

Maintain, implement and continually improve the Quality Management System (QMS) in accordance with ISO 9001, ISO 13485 and applicable customer/regulatory requirements.Ensure quality procedures, work instructions, forms and controlled documents are properly established, reviewed, approved, maintained and updated. Manage document control activities including document revision, distribution and obsolescence control.Monitor the effectiveness of QMS processes through KPI monitoring, trend analysis, and performance reporting. Coordinate certification, surveillance, customer, and regulatory audits. Plan, coordinate and conduct internal quality audits. Coordinate certification, surveillance and customer audits. Liaise with certification bodies, customers and regulatory auditors. Ensure compliance with applicable quality management standards, customer-specific requirements, and regulatory requirements. Coordinate the maintenance and renewal of quality management certifications (e.g., ISO 9001 and ISO 13485). Prepare quality reports, KPI reports, audit reports, and management presentations. Ensure proper control, filing, and traceability of QMS records. Coordinate the calibration of measuring and test equipment to ensure compliance with QMS requirements and established calibration schedules. Monitor overdue calibration items and follow up with the respective departments to ensure timely completion. Investigate out-of-tolerance calibration results and coordinate product impact assessments where applicable. Support supplier qualification, evaluation, approval, and periodic performance monitoring in accordance with QMS requirements. Ensure purchased materials and components meet specified quality requirements by reviewing inspection results, investigating quality issues, and communicating approved or non-approved results to suppliers with appropriate analysis and reports. Coordinate Material Rejection Reports (Supplier), monitor suppliers' corrective actions, and verify the effectiveness of actions implemented to prevent recurrence. Support supplier development activities to improve supplier quality performance and compliance with QMS requirements. Manage and oversee Incoming Quality Control (IQC) activities to ensure incoming materials comply with established specifications and quality requirements. Participate in supplier audits and supplier performance reviews as required. Support new customer quality system requirements and compliance initiatives. Participate in cross-functional projects related to the Quality Management System. Perform any other duties assigned by Management Requirements: Diploma or Bachelor's Degree in Engineering, Quality Management, Manufacturing, or a related discipline. Minimum 2–3 years of relevant experience in Quality Assurance or Quality Management Systems (QMS) within a manufacturing environment. Experience with ISO 9001 is required. Experience with ISO 13485 and medical device manufacturing is an added advantage. Experience in internal and external audits, CAPA, document control and supplier quality management. Good knowledge of ISO 9001 and ISO 13485 Quality' Certification as an ISO 9001 and/or ISO 13485 Internal Auditor is an added advantage. Knowledge of document control, internal auditing, CAPA, supplier quality management, calibration control, and continual improvement. Knowledge of quality tools and problem-solving methodologies, such as; 5 Why Analysis Fishbone Diagram (Ishikawa) Pareto Analysis FMEA (preferred) SPC and MSA Familiarity with Microsoft Office applications, especially Excel, Word, and PowerPoint