Establishment and continuously improvement of quality systems to ensure overall customer satisfaction
Manage and control all quality control activities in accordance with identified Quality Assurance standards, company procedures, client specifications and requirements
Liaise with internal / external parties such as governing bodies, certification bodies on all related issues
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Responsible for coordinating revisions to Acceptance Procedures with Masimo Corporate;
Ensures that required inspection equipment is available, maintained, and calibrated;
Initiates actions required to prevent and/or eliminate the occurrence or recurrence of all nonconformities relating to the product, process, and/or quality system.
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Ensure risk of non-compliance and related business risks are mitigated
Provide quality / technical leadership through mentoring/coaching
Ensure compliance to ResMed QMS; strong knowledge, application of and compliance to FDA Quality System Regulations, GMP, and applicable ISO / regulatory standards
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Understand and audit on production line process and equipment setup. Ensure all the documents (PWI) used for process are tally with BOM/Engineering and assembly drawing.
Inform the superior and concerned departmental representatives on the nature of non-conformance detected during auditing.
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Documents products that do not meet technical specifications using specified systems. Trains others in the use of measurement equipment, segregation of non-conforming product and documentation.
Follows the norms and standards of quality defined by the Company.
Reports progress on problem resolution to management. Assists in the development of new methods and procedures.
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Ensure, through training and verification, the appropriate use of current documentation, as well as the use of good documentation practices during all the stages of manufacturing.
Ensure and monitor the applicable documents for Quality inspection are available in the point of use, this includes, but is not limited to the visual aids with physical samples.
Continuously assess and improve incoming quality inspection processes to enhance efficiency, accuracy, and reliability. Identify opportunities for automation and optimization to streamline workflows
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