Principal Quality Engineer

Job Summary

A company is looking for a Principal Quality Engineer.

Key Responsibilities

• Develop, maintain, and improve the Quality System across the Americas
• Ensure compliance with US and international quality requirements and manage Notified Body communications
• Lead and support internal and external quality audits, ensuring timely completion of corrective actions

Required Qualifications

• BS degree or equivalent in engineering or life science discipline
• Minimum of 8 years' experience in a highly regulated industry
• Proficient in Risk Management practices and Regulatory Requirements (FDA, QSRs, ISO 13485)
• Experience in audit management and project leadership with cross-functional teams
• Self-motivated with a strong sense of urgency to address issues