Quality Management System Engineer

A QMS Engineer (Quality Management System Engineer) is a professional responsible for developing, implementing, maintaining, and improving an organization’s Quality Management System to ensure products or services meet regulatory, customer, and internal requirements.

Core Responsibilities

Develop and maintain QMS documentation (policies, procedures, SOPs)

Ensure compliance with standards such as ISO 9001, ISO 13485, IATF 16949, AS9100, or FDA 21 CFR

Plan and conduct internal audits and support external audits

Manage CAPA (Corrective and Preventive Actions)

Handle nonconformances, root cause analysis, and risk management

Monitor quality metrics and drive continuous improvement

Train employees on quality procedures and standards

Support supplier quality and customer audits

Core Responsibilities

• Develop and maintain QMS documentation (policies, procedures, SOPs)
• Ensure compliance with standards such as ISO 9001, ISO 13485, IATF 16949, AS9100, or FDA 21 CFR
• Plan and conduct internal audits and support external audits
• Manage CAPA (Corrective and Preventive Actions)
• Handle nonconformances, root cause analysis, and risk management
• Monitor quality metrics and drive continuous improvement
• Train employees on quality procedures and standards
• Support supplier quality and customer audits

Key Skills

• Strong knowledge of quality standards and regulations
• Documentation and process-mapping skills
• Root cause analysis tools (5 Whys, Fishbone, FMEA)
• Audit skills (internal, supplier, certification)
• Attention to detail and analytical thinking
• Communication and cross-functional collaboration

Preferred Background

• Bachelor’s degree in Engineering, Quality, or a related field
• Certifications (often preferred):
• ISO 9001 Lead Auditor
• CQE (Certified Quality Engineer – ASQ)
• Six Sigma Green/Black Belt