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Director of Global Product Quality

VirtualVocations
Carrollton, Texas, United States
Full-time

A company is looking for a Director, Global Product Quality Assurance, Digital Products Development.Key ResponsibilitiesDevelop and oversee the Quality Management System for medical device hardware and software as a medical device (SaMD) productsLead design control, risk management, and post-market surveillance activities for medical devicesCollaborate with various teams to integrate quality into product development and support regulatory submissionsRequired Qualifications10 years of Quality Management experience with GxP-compliant product developmentExpertise in FDA 21 CFR Parts 820, Part 4 and ISO 134855 years of experience in internal / external auditing and managing supplier auditsBachelor's Degree in Engineering or Physical Sciences with relevant experienceKnowledge of HIPAA and GDPR

20 hours ago
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