16 Sep
|
Vitalbio
|
Ontario
Vital Bio seeks a Quality Systems Manager with robust medical device experience to maintain high-quality standards. This hybrid opportunity allows you to impact quality management and compliance across creative projects.
You will take ownership of the Quality Management System, driving continuous improvement and ensuring compliance with regulatory standards like ISO 13485 and FDA QMSR. Your role will involve leading quality audits, managing CAPA processes, and implementing necessary quality system enhancements. You will partner with cross-functional teams to ensure quality is embedded within all stages of product development and supply chain operations.
Key Responsibilities:
• Drive quality management and compliance with ISO regulations
• Lead audits and inspections, ensuring readiness and compliance
• Manage and optimize eQMS processes and workflow
• Collaborate on internal quality and regulatory inspections
• Monitor and report quality trends through dashboards
Requirements:
• Bachelor’s in Engineering, Biomedical Engineering, or similar
• Minimum 7 years of experience in Quality Assurance
• Extensive knowledge of eQMS platforms and ISO 13485
• Background in product development and design controls
• Strong analytical and leadership skills
Become a pivotal force at Vital Bio, ensuring exceptional quality standards across healthcare innovations.
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📌 Quality Manager in Medical Device Sector (Ontario)
🏢 Vitalbio
📍 Ontario