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Director of Global Product Quality

Company: VirtualVocations
Location: Metairie
Posted on: October 30, 2024

Job Description:

A company is looking for a Director, Global Product Quality Assurance, Digital Products Development.



Key Responsibilities

Develop and oversee the Quality Management System for medical device hardware and software as a medical device (SaMD) products
Lead design control, risk management, and post-market surveillance activities for medical devices
Collaborate with various teams to integrate quality into product development and support regulatory submissions


Required Qualifications

10 years of Quality Management experience with GxP-compliant product development
Expertise in FDA 21 CFR Parts 820, Part 4 and ISO 13485
5 years of experience in internal/external auditing and managing supplier audits
Bachelor's Degree in Engineering or Physical Sciences with relevant experience
Knowledge of HIPAA and GDPR

Keywords: VirtualVocations, Gulf Port , Director of Global Product Quality, Executive , Metairie, Mississippi

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