Become an integral part of Excelitas Technologies as a Quality Engineer II in Mississauga. This full time role emphasizes compliance and quality assurance for medical devices, ensuring adherence to FDA and ISO regulations.
As a Quality Engineer II, you will assist in implementing and maintaining QMS processes vital for medical device production. Your responsibilities include conducting audits, analyzing supplier performance, and engaging with internal teams to foster quality enhancements. Your expertise will play a critical role in reducing product non-conformances and securing customer satisfaction.
Key Responsibilities:
• Manage the supplier QMS audit program
• Conduct internal audits for compliance verification
• Facilitate communication with engineering teams
• Analyze supplier manufacturing processes
• Oversee supplier corrective action plans
Requirements:
• 3-6 years in Medical Device Quality Assurance
• Experience with ISO 13485 and FDA 21 CFR Part 820
• Bachelor’s degree in engineering
• Internal auditor credentials preferred
• Proficiency in quality methodologies like FMEA
Leverage your quality assurance expertise to help Excelitas uphold high standards in medical device manufacturing.
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📌 Excelitas Quality Engineer II Position (Ontario)
🏢 Excelitas Technologies
📍 Ontario
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