California Licensed Senior Quality Manager

Job Summary

A company is looking for a Senior Manager, Quality Core Team.

Key Responsibilities

• Provide oversight and functional expertise for new product development (NPD) projects as the voice of quality
• Manage quality-related initiatives and ensure compliance with quality systems throughout the product development process
• Drive measurable quality improvements and manage quality escalations by collaborating cross-functionally

Required Qualifications

• Bachelor of Science in a medical, engineering, or scientific discipline; Design or Process Green/Black Belt is a plus
• Minimum of 8 years of experience in a drug/device manufacturer/distributor focusing on quality assurance
• At least 5 years of experience supporting new product development, with 3+ years as a Quality Core Team member
• Knowledge of medical device regulations and standards (e.g., 21CFR part 820, ISO 13485, ISO 14971)
• Strong technical skills related to product quality and familiarity with FDA QSR's and risk management practices