Assist Quality Manager on the quality assurance and product quality
Supports product manufacturing through the application of quality engineering tools
Assure conformance of systems and processes during manufacture, and quality control operations with respect to internal procedures, Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR) and other applicable international standards and regulations
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Assist Quality Manager on the quality assurance and product quality
Supports product manufacturing through the application of quality engineering tools
Assure conformance of systems and processes during manufacture, and quality control operations with respect to internal procedures, Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR) and other applicable international standards and regulations
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Supports, troubleshoots and maintains Corporate and Manufacturing systems (i.e. deploying enhancements/bug fixes).
Collaborate with team members (project manager, software developers, systems and network engineer) in a fast-paced environment to meet project milestones.
Systems validation and documentation meet predetermined guidelines for compliance.
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Supports, troubleshoots and maintains Corporate and Manufacturing systems (i.e. deploying enhancements/bug fixes).
Collaborate with team members (project manager, software developers, systems and network engineer) in a fast-paced environment to meet project milestones.
Systems validation and documentation meet predetermined guidelines for compliance.
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Process Management: Develop, implement, and maintain effective processes and workflows for backend operations in semiconductor manufacturing. This includes processes such as assembly, packaging, testing, and quality control. Ensure adherence to industry standards, specifications, and quality requirements.
Team Coordination: Coordinate and collaborate with cross-functional teams, including engineers, technicians, operators, and quality assurance personnel, to ensure the seamless integration and execution of backend processes.
Equipment and Tooling: Identify, evaluate, and recommend appropriate equipment, tools, and materials for backend operations. Collaborate with equipment engineers to ensure optimal performance, maintenance, and calibration of equipment.
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Process Management: Develop, implement, and maintain effective processes and workflows for backend operations in semiconductor manufacturing. This includes processes such as assembly, packaging, testing, and quality control. Ensure adherence to industry standards, specifications, and quality requirements.
Team Coordination: Coordinate and collaborate with cross-functional teams, including engineers, technicians, operators, and quality assurance personnel, to ensure the seamless integration and execution of backend processes.
Equipment and Tooling: Identify, evaluate, and recommend appropriate equipment, tools, and materials for backend operations. Collaborate with equipment engineers to ensure optimal performance, maintenance, and calibration of equipment.
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Perform and support incoming, in-process, and final inspections to ensure product compliance with specifications and quality requirements.
Monitor product yield, defect trends, and quality KPIs to identify improvement opportunities.
Conduct investigations on product nonconformance, customer complaints, returned products, and field issues to identify root causes and corrective actions.
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Assist Quality Manager on the quality assurance and product quality
Supports new product development and product manufacturing through the application of quality engineering tools
Assure conformance of systems and processes during the development, manufacture, and quality control operations with respect to internal procedures, Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR) MDD 93/42 EEC and other applicable international standards and regulations
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Develop project plans, timelines, and budgets for the projects.
Coordinate resources, tasks, and activities to ensure timely and efficient project execution.
Collaborate with cross functional teams including engineers, planner, production, buyer to ensure effective communication, coordination, and collaboration throughout the project lifecycle.
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Conduct thorough inspections of incoming materials and components to ensure they meet established quality standards, specifications, and regulatory requirements.
Maintain accurate records of inspection results, test data, and any deviations from quality standards. Collect & maintain COC and all docs related to incoming material. Document non-conforming materials and initiate appropriate corrective actions.
Collaborate with supplier quality team to address quality issues, improve incoming material quality, and establish effective communication channels for resolving quality-related concerns.
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Develop project plans, timelines, and budgets for the projects.
Coordinate resources, tasks, and activities to ensure timely and efficient project execution.
Collaborate with cross functional teams including engineers, planner, production, buyer to ensure effective communication, coordination, and collaboration throughout the project lifecycle.
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Perform and support incoming, in-process, and final inspections to ensure product compliance with specifications and quality requirements.
Monitor product yield, defect trends, and quality KPIs to identify improvement opportunities.
Conduct investigations on product nonconformance, customer complaints, returned products, and field issues to identify root causes and corrective actions.
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Following to quality system and good manufacturing practices.
Performs routine maintenance on equipment as requested by Maintenance Supervisor and perform work orders for corrective and preventive maintenance.
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This position primarily works in indoor facilities. It requires frequent sitting, standing and walking. It may stand for extended periods walking in the facilities. Must be able to lift and carry up to 15 Kg, and climb a vertical ladder. Must have knowledge of work on hot surfaces, because you will have direct contact with molding equipment with high temperatures, have knowledge in the use of personal protective equipment for solvents. The Maintenance Technician may only use hand tools, impact tools, hand saws, hand drills, hammers and low risk equipment. The use of all equipment and accessories that represent a high risk such as bench cutting tools, electric cutting saws, manual bow saws, etc. is prohibited. Always using personal protective equipment where applicable for the execution of maintenance activities.
Following to quality system and good manufacturing practices.
Performs routine maintenance on equipment as requested by Maintenance Supervisor and perform work orders for corrective and preventive maintenance.
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The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described