Elevate your career as a Quality Engineer II with Excelitas Technologies in Mississauga, ON. This full-time role focuses on QMS implementation for medical devices, ensuring compliance with FDA and ISO standards.
In this pivotal position, you will support the Quality team in managing the Quality Management System (QMS) for medical devices. You will perform supplier audits, collaborate with engineering teams, and analyze quality data to drive continuous improvement. Your work will significantly impact product quality and operational efficiency.
Key Responsibilities:
• Conduct supplier QMS audits and trend analysis
• Perform internal QMS audits regularly
• Collaborate with teams for quality improvement
• Review supplier processes and enhance value
• Implement supplier corrective action programs
Requirements:
• 3-6 years in Medical Device Quality Assurance
• Hands-on experience with ISO 13485 and FDA 21 CFR 820
• Bachelor's degree in engineering or related field
• Internal auditor experience in ISO13485
• Solid understanding of CAPA and root cause analysis
Utilize your quality engineering skills to support Excelitas Technologies and enhance operational excellence.
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📌 Quality Engineer II at Excelitas Technologies (Mississauga)
🏢 Excelitas Technologies
📍 Mississauga