Quality Engineer I

Zimmer Biomet seeks a Quality Engineer I in Montreal to ensure medical device products meet regulatory, quality, and customer requirements throughout design, development, and product lifecycle. The role involves cross-functional collaboration on design controls, risk management, compliance documentation, and quality improvements within a medical technology company.

Responsibilities

• Execute quality tasks within design, development, and change control processes
• Review, maintain, and approve Design History Files and Risk Management Files
• Identify and mitigate design risks using FMEA and statistical tools
• Support design verification, validation, and regulatory submission activities
• Analyze quality data to identify trends and drive improvement initiatives

Requirements

• Bachelor's degree in Engineering or related field
• Experience in design controls, verification, and validation activities
• Working knowledge of FDA 21 CFR 820.30, ISO 13485, and EU MDR
• Understanding of risk management, FMEA, and statistical analysis tools
• Strong technical writing and cross-functional communication skills
• Proficiency in statistical data analysis
• Six Sigma Yellow or Green Belt certification preferred