Quality Assurance Manager

Job Summary

A company is looking for a Design Assurance Manager.

Key Responsibilities

• Oversee the Quality Management System (QMS) and ensure compliance with standards and regulations
• Facilitate Corrective and Preventive Actions (CAPAs) and support internal and third-party audits
• Provide training and coaching on QMS and assist in continuous improvement initiatives

Required Qualifications

• Bachelor's degree in Engineering or a related field; Master's degree preferred
• 7+ years of experience in regulated industries such as medical devices or aerospace
• Knowledge of key standards (ISO 13485, AS9100, etc.) and regulations
• Experience with documentation control, record retention, and CAPA facilitation
• ISO 13485 Lead Assessor certification preferred; CQE beneficial