Quality Assurance Manager

Job Description

Role & responsibilities Quality Assurance & Control Management of the quality department in the production carried out in the company. Develop, implement, and manage the Quality Management System (QMS) to meet company and industry standards. Lead Incoming Quality Control (IQC), In-Process Quality Control (IPQC), and Outgoing Quality Control (OQC) to ensure product conformance. Analyze in-process and final product defects, implement corrective and preventive actions (CAPA), and drive continuous improvement initiatives. Oversee quality-related documentation, including inspection reports, quality records, and non-conformance reports (NCRs). Handle customer concerns and claims, ensuring timely resolution and root cause analysis. Conduct supplier evaluations and new material assessments to maintain quality consistency and optimize supply chain performance. Monitor and improve production KPIs to ensure compliance with quality standards and efficiency goals. Process Improvement & Compliance Establish and drive continuous improvement initiatives using Lean, Six Sigma, and other quality tools. Ensure compliance with ISO standards and serve as the Quality Management Representative (QMR) for audits and certifications. Establish, Maintain and update the traceability to formalize changes in 5M (Man, Machine, Method, Material, Measurement) and 1E (Environment). Conduct internal audits to verify process compliance and identify areas for improvement. To support and work for the production engineering matter to improve the quality in the entire process. Team Leadership & Training Lead and mentor the quality team, including training newly hired technicians and production staff. Develop and implement a training and development plan for the quality department and cross-functional teams. Foster a culture of quality awareness and accountability across departments. 3D Printer-Specific Quality Management Oversee 3D printer operation and maintenance, ensuring optimal performance and print quality. Track and reduce material waste while improving efficiency in 3D printing production. Work closely with engineering teams to optimize firmware configurations and print parameters for prosthetic parts and other applications. Drive improvements in 3D printer technology to enhance speed, reliability, and cost-efficiency. Reporting & Documentation Generate and present monthly quality reports covering IQC, IPQC, OQC, and other key quality activities. Establish and maintain quality data tracking systems, including production lead times, defect rates, and maintenance records. Collaborate with production, R&D, and customer service teams to resolve quality-related challenges. Preferred candidate profile Bachelors degree in Mechanical Engineering, Industrial Engineering, Quality Management, or a related field. 5+ years of experience in quality management, preferably in a 3D printer manufacturing or high-tech production environment. Strong knowledge of ISO 9001, Six Sigma, Lean Manufacturing, and other quality methodologies. Experience with process audits, root cause analysis, and CAPA implementation. Ability to read engineer drawings and knowledge of necessary symbols and usage of tolerances and GD&T. Experience with creating checklist documentation for quality checkpoints for material acceptance. Excellent leadership, communication, and problem-solving skills. Proficiency in data analysis tools (Excel, Minitab, Power BI) and QMS software. WANT Experience in ISO 9001 maintenance audits and related evaluations Experience in team management in the quality department (managing at least three members). NICE TO HAVE Experience in quality control operations at a Japanese company. Familiarity with 3D printing technology, materials, and firmware configurations.