Leads and participates in problem solving activities related to design, manufacture and inspection and test, including CAPA, NCR and supplier related issues
Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution.
Review and verify completeness and accuracy of Device History Records (DHRs) to ensure all manufacturing, inspection, and testing activities are properly documented and meet product specifications and regulatory requirements
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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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Leads and participates in problem solving activities related to manufacture and inspection and test, including NCR and supplier related issues
Communicates significant issues or developments during quality inspection activities and through analysis provides plans and recommendations to the team and management for resolution
Leads and/or participates in IQ/OQ and PQ activities, test sample size selection, test method validations, Gage R&R studies and risk management activities to assure conformance to product quality standards and applicable regulations
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Performs and documents initial reportability decisions on complaints in accordance with regulations (US FDA) and international regulations (MEDDEV Vigilance, Health Canada, and others as applicable) and company procedures; Elevate complaints that require additional review for regulatory reporting.
Verify that the correct number of complaints have been opened to address all of the issues identified in the complaint description. If required, generate additional complaint records to document all of the issues listed in the complaint description.
Ensure that all complaints requiring customer responses are properly addressed, as assigned; drafts and documents the response in the complaint file.
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Ensure all project activities comply with contractual quality requirements and statutory regulations.
Keep up to date with revisions in standards and advise the project team accordingly.
Review of all quality deliverables i.e procedures, NCR close-out, Quality MOM, to ensure alignment with contract requirement, client specification and statutory requirements.
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Memeriksa dimensi, keadaan fizikal, plating dan ciri-ciri kualiti produk menggunakan peralatan pengukuran yang sesuai.
Menjalankan pemeriksaan visual bagi mengenal pasti kecacatan seperti calar, pencemaran, perubahan bentuk, kecacatan plating dan ketidaknormalan dimensi.
Menjalankan pemeriksaan sampel berdasarkan arahan kerja, standard pemeriksaan dan control plan.
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