Quality Systems Specialist

Job Summary

A company is looking for a Sr Quality Systems Spec.

Key Responsibilities

• Oversee the development and maintenance of quality programs, systems, processes, and procedures to ensure compliance with established standards
• Provide expertise and guidance in interpreting policies and regulatory requirements to assure compliance
• Lead audit and inspection preparation, manage findings, and coordinate legal requests for government investigations

Required Qualifications

• Bachelor's degree with a minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years of relevant experience
• Experience in Quality Systems Management, particularly in Production and Process Controls within regulated industries
• Project leadership or management experience
• Knowledge of QMS Document change management
• Proficiency in Agile systems for change control and technical writing