Plan, conduct, and document QMS internal audits in accordance with established audit schedules and company procedures.
Evaluate compliance with applicable regulations, standards, and quality system requirements, including ISO 13485, 21 CFR Part 820, EU MDR 2017/745 and other relevant global regulatory requirements.
Evaluate the effectiveness of quality system processes and ensure they are adequately documented, implemented, and maintained.
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Collaborate with the production team to obtain precheck lists and verify the completion of necessary manufacturing steps for autonomous mobile robots.
Conduct detailed quality control inspections on autonomous mobile robots, including visual inspections, functional tests, and burnout tests to ensure compliance with established specifications, standards, and safety regulations.
Utilize various testing equipment and tools, such as multimeters, oscilloscopes, power supplies, and specialized software, to perform accurate and reliable assessments of product performance and functionality.
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Auditing: Supports the planning and execution of plant quality system audits by conducting compliance assessments and providing recommendations and guidance to ensure applicable quality and regulatory standards are met. Prepares audit summaries, tracks corrective action implementation, and provides regular progress updates to the Associate Manager, QRC.
Documentations: Reviews plant compliance against global procedures, policies, and standards, identifies gaps, and supports the implementation and follow up of corrective actions. Supports risk assessment verification and navigation activities to ensure effective risk control and compliance outcomes.
Training: Supports the development and delivery of training programs related to regulatory, religious, and quality requirements, and conducts and coordinates QA training programs to ensure plant personnel are adequately trained and compliant with applicable standards.
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Sustaining Production Excellence: Provide real-time technical support to daily manufacturing operations, rapidly troubleshooting issues to minimize equipment downtime and maximize asset utilization.
Technical Tool Competency: Demonstrate advanced proficiency in utilizing core engineering tools, diagnostic equipment, and specialized software to maintain peak system performance.
Proactive Problem Solving: Drive root-cause analysis on equipment and process anomalies, implementing preventive actions to mitigate repetitive failures before they disrupt production schedules.
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Sustaining Production Excellence: Provide real-time technical support to daily manufacturing operations, rapidly troubleshooting issues to minimize equipment downtime and maximize asset utilization.
Technical Tool Competency: Demonstrate advanced proficiency in utilizing core engineering tools, diagnostic equipment, and specialized software to maintain peak system performance.
Proactive Problem Solving: Drive root-cause analysis on equipment and process anomalies, implementing preventive actions to mitigate repetitive failures before they disrupt production schedules.
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Adhere to and comply with all safety and health procedures and regulations set by management/authority, and report to the OSH Committee any unsafe acts, situations, or practices observed.
Ensure the operation of the cold end area follows the Standard Operating Procedures (SOP) and complies with ISO 9001:2015 quality standards and HACCP standards.
Direct, plan, and control overall quality operations within the Quality & Systems department.
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Global QMS Management: Drive the creation, approval, and ongoing maintenance of worldwide Supplier Quality Management System (SQMS) documents, collaborating with key stakeholders to ensure timely execution.
Audit Program Oversight: Lead the risk-based global supplier audit program. Schedule and prioritize audits for critical suppliers based on risk assessments and maintain compliance with worldwide procedures.
Auditor Roster Management: Maintain the global qualified auditor register, ensuring qualified auditors are appropriately assigned to audit engagements.
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Handle highly complex technical tasks to support operations and enhance efficiency within defined procedures
Make significant decisions within your task scope, requiring advanced technical skills and problem-solving abilities
Monitor systems and processes, perform audits and inspections, identify issues, and implement corrective actions to maintain product quality and safety
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Develops, implements, and maintains technical quality assurance and control systems and activities.
Defines and specifies the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of the construction and future operation management.
Participates in the reviewing of engineering designs to contribute quality requirements and considerations.
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Reports to Sr. Quality Manager on CM Quality related tasks.
Act as the primary quality interface in CM division
Monitor CM quality performance (QPPM, FPY, NCRs, Audits, customer scorecards etc). Review and approve quality documents and ensure CM's compliance to ISO 9001 or other industry standards.
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Develops, implements, and maintains technical quality assurance and control systems and activities.
Defines and specifies the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of the construction and future operation management.
Participates in the reviewing of engineering designs to contribute quality requirements and considerations.
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Develops, implements, and maintains technical quality assurance and control systems and activities.
Defines and specifies the implementation of standards, methods, and procedures for inspecting, testing, and evaluating the precision, accuracy, and reliability of the construction and future operation management.
Participates in the reviewing of engineering designs to contribute quality requirements and considerations.
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