Engineer, Quality

The Quality Engineer is responsible for providing technical input for quality engineering throughout the product manufacturing process. The incumbent provides a key role to ensure product meets defined production quality standards.

Requirements

• 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
• 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
• Develops and manages programs that monitor, predict, or regulate manufacturing, and inspection activities. This may be accomplished through the application of statistical tools such as Minitab and/or SQC pack
• In conjunction with the QA management, ensures robust application of the quality system by supporting the quality compliance process including the generation of data for NCR, RI and in process inspections.
• Works with the quality manager to report effectiveness of the quality management system to Masimo’s management representative.
• Any reasonable task assigned by manager, as applicable