Head of Product Quality

Remote Remote · Remote - USA

go hardware engineering

greenhouse

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Job description

You will manage PAX's Quality Management System while ensuring compliance for medical device launches. This role involves overseeing quality processes and collaborating with various teams to maintain high standards.

Details

Remote - USA
10+ years of experience in quality engineering in a regulated hardware environment
Skills: ISO 13485, risk management, document control, CAPA

The work

Own and improve PAX's Quality Management System based on ISO standards
Review and approve test plans and reports for new product development
Manage the risk management process aligned with ISO 14971 principles
Lead internal audits and serve as the primary contact for external audits