California Licensed Quality Manager

Job Summary

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

Key Responsibilities

• Provide oversight and represent the voice of quality on cross-functional new product development (NPD) project teams
• Manage quality-related initiatives and ensure compliance with quality system requirements
• Drive quality improvements and risk management strategies throughout the product development process

Required Qualifications

• Bachelor of Science in a medical, engineering, or scientific discipline
• Minimum of 8 years of experience in drug/device manufacturing with a focus on quality assurance
• At least 5 years of experience supporting new product development as a Quality Core Team member
• Knowledge of medical device regulations and quality standards (e.g., 21CFR part 820, ISO 13485)
• Proven project management skills and strong technical skills related to product quality