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The Quality Manager is responsible for overseeing the Quality function and the Quality Management System (QMS) to ensure that products consistently meet the requirements of customers, stakeholders, and regulatory standards. This role encompasses the development and implementation of robust quality control processes, conducting product inspections at critical stages of production, and preparing comprehensive reports that document and address production issues in a timely and effective manner.
Responsibilities
Establish and maintain quality standards, procedures and controls.
Develop, implement and maintain the activities of quality control systems.
Oversee the development and implementation of standards, methods and procedures for inspecting, testing and evaluating the precision, accuracy and reliability of company products.
Full ownership of customer change management processes and qualification activities related to expanding operations in Singapore and Malaysia.
Approve product acceptance testing, quality plans, and other technical quality-related matters.
Review and approve quality and project documentation to ensure compliance with customer, regulatory and company requirements.
Lead and perform internal audits of products, processes and procedures, and drive corrective and preventive actions as required.
Make recommendations and implement corrective actions necessary to ensure conformity with quality specifications and continuous improvement objectives.
Select, develop and evaluate personnel to ensure the efficient and effective operation of the Quality
Requirements
Bachelor's Degree in Electrical Engineering, Mechanical Engineering, Industrial Engineering, or a related discipline.
Minimum 10 years of Quality and/or Engineering experience in a manufacturing environment, with at least 5 years in a management role.
Experience in a high-mix, low-volume manufacturing environment semiconductor industry experience is preferred.
Strong knowledge of quality management systems, audit processes, and corrective and preventive action (CAPA) methodologies.
Proficient in quality tools and methodologies, including 8D problem solving, Root Cause Analysis, FMEA, and Statistical Process Control (SPC).
Excellent communication, presentation, and technical writing skills.
Strong analytical and problem-solving skills with a systematic and data-driven approach.
Proven ability to lead, develop, and motivate teams while driving a culture of quality and continuous improvement.
Experience interfacing with customers, managing customer audits, and resolving quality-related issues is preferred.
Job ID: 149285509
Skills:
Iso 13485, IEC 62304, Control Inspection Plans, Iso 14001, Fmea, Spc, FDA 21 CFR Part 820, IEC 60601-1, Iso 9001, Doe, Pfmea, Msa
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