Quality Engineer – Systems

About the role

The Quality Engineer (Systems) ensures that the company’s quality management systems meet internal standards, customer requirements and regulatory obligations. Working closely with cross‑functional teams, the engineer monitors documentation, change and risk management processes and drives continuous improvement across the organization.

Key responsibilities

• Maintain compliance with industry regulations (ISO, R2V3, etc.) across all QMS.
• Lead internal and external quality system audits, coordinate schedules and manage corrective actions.
• Identify compliance risks, propose mitigation strategies and monitor their implementation.
• Control quality records in line with retention and regulatory requirements.
• Lead or support CAPA activities and ensure timely closure of quality events, deviations and audit findings.
• Collaborate with product development, operations and legal teams to ensure global regulatory compliance.
• Represent the quality system during regulatory inspections and customer audits.
• Stay current on applicable regulations, standards and industry trends.

Required profile

• Bachelor’s degree in Industrial, Mechanical or Manufacturing Engineering or related field.
• Minimum 2 years of process quality engineering experience in a manufacturing environment.
• Bilingual in English and Spanish.
• Valid U.S. visa and ability to travel to the United States as required.
• Strong knowledge of quality tools and methodologies.
• Proficiency with Microsoft Office suite.

Required skills

• FMEA, SPC, MSA.
• ISO 9001 (preferred).
• Root‑cause analysis tools: 8D, 5 Why’s, Ishikawa.
• Lean Manufacturing, Six Sigma, continuous improvement techniques.
• Microsoft Excel, Word, PowerPoint.

What we offer

• Competitive salary.
• Opportunities for professional growth and development.
• Supportive and collaborative work environment.
• Comprehensive benefits package.