QMS Process Improvement Engineer

Job Description Summary

The QMS Leader/Process Engineer will be responsible for the overall development, implementation, maintenance, and continuous improvement of the Quality Management System (QMS) in compliance with ISO 9001 standards. This role requires collaboration across all departments to ensure the QMS is fully understood and embraced throughout the manufacturing site, while ensuring that all processes, documentation, and quality controls meet regulatory and customer requirements. By driving operational excellence and product quality, this position plays a critical role in sustaining compliance and fostering a culture of quality.

Job Description

Essential Responsibilities

1. Safety

• Owns and champions safety record and safety culture, Partners with EHS team to identify processes or equipment that can be improved to eliminate safety hazards,
• Maintains the highest standards of integrity while complying with company initiatives and administering local policies

• Maintain and improve the ISO 9001-compliant QMS, ensuring alignment with organizational goals and regulatory requirements.
• Develop, review, and update quality procedures, work instructions, and policies.
• Ensure proper document control and record retention per ISO standards.

• Lead and conduct gap analyses and internal audits to verify compliance with ISO 9001 requirements.
• Work with production to identify processes that can be improved to leverage productivity and implement corrective/preventive actions (CAPA) and manage corrective actions & controls around reduction of COQ.
• Lead root cause analysis and problem-solving initiatives for quality issues.

• Provide training and guidance to employees on QMS requirements, procedures, and best practices.
• Drive a "quality culture" to the production floor and across all departments with a focus on continuous improvement, and a no defect philosophy.

• Monitor key quality metrics (KPIs) to evaluate system effectiveness.
• Prepare and present QMS performance reports to management.
• Support management reviews and QMS audits.

• Work closely with production, engineering, and supply chain teams to ensure quality standards are met.
• Collaborate with co-workers and customers on quality-related issues and requirements.

• Bachelor's degree (or 5 years within manufacturing quality related position), and
• Additional 3 years of experience in quality engineering or QMS management in a manufacturing environment
• Strong knowledge of ISO 9001 standards and auditing practices
• Experience with QMS software and ERP systems.

• Bi-lingual (Sp)
• Six Sigma training
• Proficiency in root cause analysis
• Ability to apply statistical methods to analysis of engineering problems
• Ability to comprehend technical documentation
• Strong oral and written communication skills
• Strong interpersonal and leadership skills
• Certification as ISO 9001 Lead Auditor
• Familiarity with other standards (ISO 14001) is a plus