Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR requirements, and applicable medical device regulations.
Perform quality inspections, product testing, and verification activities to ensure products meet customer specifications and regulatory requirements.
Manage quality documentation and records, including Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), change controls, and quality reports.
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Develop, implement, and maintain the Quality Management System (QMS) in compliance with ISO 13485, FDA QSR requirements, and applicable medical device regulations.
Perform quality inspections, product testing, and verification activities to ensure products meet customer specifications and regulatory requirements.
Manage quality documentation and records, including Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), change controls, and quality reports.
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Quality Assurance: Assist in implementing quality assurance processes to ensure that products meet customer drawings, specifications, and quality standards by performing inspections and verifying critical dimensions.
Process Improvement: Support process improvement activities to enhance overall product quality and efficiency.
Quality Control: Conduct inspections and collaborate with production teams to address quality issues in real-time.
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Develop and maintain QA plans and timeliness of global new product introductions utilizing Advanced Product Quality Planning and Process Optimization specific to the customer.
Provide support for all quoting activities by participation in initial process design, development, and implementation phases.
Evaluate and provide input to inspection processes via inspection aids and instruction guidelines.
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