Quality Management System (QMS)- Medical Device & Regulations || Blue Ash, OH

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Savi Technologies LLC

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9:57 AM (5 hours ago) 9:57 AM

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Job Title: Quality Management System (QMS)- Medical Device & Regulations
Location: Blue Ash, OH

Responsibilities:
Support and maintain Quality Management System (QMS) processes in compliance with regulatory requirements Collaborate with cross functional teams to deliver quality compliant outcomes Interpret and apply medical device regulations and standards to projects and processes
Drive complaint handling| post market surveillance| risk management| NC| and CAPA activities
Support audits and regulatory inspections| ensuring timely closure of actions
Perform and review risk assessments (FMEA| ISO 14971)
Manage quality deliverables for multiple projects| ensuring timelines and quality goals are met