Engineer, Quality

Duties & Responsibilities

• 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 ris...