Provide supports and guidance for vendors in improving the quality management system per Medline internal audit SOP and applicable regulations as ISO 13485, FDA regulations, QSR part 820, MDR 2017/745, ISO9001, ASTM standards and etc..
Response to vendors’ questions;
Necessary instruction, guidance and training for suppliers;
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Drive Design for Manufacturability (DFM) and Design for Reliability principles, providing expertise in component design, tooling strategies, material selection, and biocompatibility considerations.
Lead process development and validation activities, including DOE, PFMEA, process capability studies, and IQ/OQ/PQ validation, utilizing scientific molding principles.
Ensure compliance with ISO 13485, FDA Quality System requirements, ISO 14971 risk management standards, and other applicable medical device regulations.
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Dealing effectively with post contract cost variances and the change control processes, where applicable referring major changes to line manager
Responsibility for making cost checks and carrying out valuations on larger projects and in all cases ensuring that timely and accurate cost checking and valuation takes place
Producing monthly post contract cost reports and presenting them to the client
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Drive Design for Manufacturability (DFM) and Design for Reliability principles, providing expertise in component design, tooling strategies, material selection, and biocompatibility considerations.
Lead process development and validation activities, including DOE, PFMEA, process capability studies, and IQ/OQ/PQ validation, utilizing scientific molding principles.
Ensure compliance with ISO 13485, FDA Quality System requirements, ISO 14971 risk management standards, and other applicable medical device regulations.
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