Assist Quality Manager on the quality assurance and product quality
Supports product manufacturing through the application of quality engineering tools
Assure conformance of systems and processes during manufacture, and quality control operations with respect to internal procedures, Quality System Regulations (FDA CFR 21 820), ISO 13485, Canadian Medical Device Requirements (CMDR) and other applicable international standards and regulations
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Perform and support incoming, in-process, and final inspections to ensure product compliance with specifications and quality requirements.
Monitor product yield, defect trends, and quality KPIs to identify improvement opportunities.
Conduct investigations on product nonconformance, customer complaints, returned products, and field issues to identify root causes and corrective actions.
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Responsible for quality compliance duties relating to customer complaints, including but not limited to preliminary classification of complaints, customer and product follow ups, maintaining investigation records and all other supporting documentations, and assign additional actions as necessary to close complaint.
Ensures complaints are processed thoroughly and timely in compliance with departmental procedures and metrics.
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