Quality Assurance Engineer

Responsibilities: - Maintain accurate and up-to-date ISO 9001, ISO 14001, and ISO 13485 documentation, including Quality Manuals, procedures, work instructions, and records, to ensure system compliance and management review readiness. - Plan, coordinate, and conduct internal and external audits to ensure organizational readiness for third-party certification, management reviews, and customer audits. - Collaborate with internal stakeholders to support and participate in customer and supplier audits to ensure compliance requirements are met. - Review audit findings, develop corrective action plans, and drive continuous improvement initiatives. - Generate and review supplier quality performance reports, work closely with suppliers to resolve non-conformances, and promote continuous improvement. - Issue, monitor, and follow up on Supplier Corrective Action Requests (SCAR), ensuring effectiveness and timely closure. - Support qualification and onboarding of new suppliers to maintain a robust pipeline aligned with production requirements. - Manage calibration schedules and preventive maintenance programs for equipment to ensure operational reliability and compliance. - Address quality issues arising from production and customer feedback by working closely with production teams to implement corrective actions and resolve customer complaints with proper documentation. - Ensure timely closure of Corrective and Preventive Actions (CAPA), non-conformance reports, and customer complaints, and publish quality performance reports. - Lead Material Review Board (MRB) meetings with cross-functional teams to perform root cause analysis, implement corrective actions, and verify effectiveness. - Supervise and lead QC inspectors to ensure parts inspection compliance with engineering drawings and quality standards. Qualifications: - Diploma in Quality Management, Engineering, Manufacturing, or a related field. - Min 3 years of relevant experience in quality or manufacturing environments, with exposure to audits and documentation. - Basic understanding of supplier management and quality coordination. - Familiarity with commonly used quality management standards (e.g. ISO systems). - Working knowledge of quality tools and process control methods.