Principal Device Quality Engineer - IVD devices SME (JP9691-C) - Remote

Overview

The Principal Device Quality Engineer will play a key role in the Quality organization, focusing on IVD devices and ensuring compliance with applicable regulations and standards.

In Short

• Work remotely until Covid restrictions are lifted.
• 5+ years of experience with IVD devices required.
• Assist with co-development and lifecycle management of diagnostic devices.
• Interact with cross-functional teams and IVD manufacturers.
• Provide thought leadership on IVD quality processes.
• Train partners on IVD requirements and standards.
• Suggest improvements to the quality system.
• Lead regulatory interactions for IVDs.
• Review and approve quality procedures.
• Ensure compliance with quality principles and regulations.

Requirements

• Doctorate with 2 years of experience or equivalent qualifications.
• 5+ years of Quality, Engineering, or Operations experience in IVD.
• Experience with quality systems and regulations (21 CFR 820, ISO 13485).
• Knowledge of Medical Device Design Controls.
• Experience in IVD clinical trials is a plus.
• Strong project management skills.
• Ability to work in a cross-functional team.
• High personal integrity and strong work ethic.
• Experience in driving improvement and implementing change.
• Interpersonal skills to teach quality principles.

Benefits

• Experience in a growing area of precision medicine.
• Exposure to innovative IVD manufacturers.