Senior Quality Systems Lead: Regulatory Compliance

STERIS; Guadalupe; On-site; MXN 900,000 - 1,300,000; Full time

Job summary

STERIS is seeking a Quality Systems Manager to lead the quality management system, ensuring regulatory compliance and robust quality processes across development, manufacturing, and distribution. The role oversees audits, CAPA, supplier quality, and continuous improvement initiatives to meet customer and business expectations.

Responsibilities include leading the quality team, maintaining ISO/FDA/MDSAP compliance, and driving quality improvements across the product lifecycle.

Qualifications

• Bilingual in English and Spanish.
• Minimum 5 years of experience in manufacturing and regulated quality environment.
• Strong knowledge of ISO 9001, ISO 13485, ISO 14971, FDA regulations, GMP, MDSAP, CE Marking, and other applicable regulatory standards.
• Proven leadership experience managing technical and quality-focused teams.
• Preferred certifications include CQE, CQA, CQMgr, Lean, or Six Sigma.

Responsibilities

• Lead and develop the Quality team, providing guidance, coaching, and performance support.
• Ensure compliance with ISO, FDA, MDSAP, EU MDR, and NOM requirements.
• Own and lead Management Review activities as site Quality Management Representative.
• Drive continuous improvement through data analysis, CAPA management, problem-solving, and quality performance monitoring.
• Oversee production, environmental, process, supplier, and complaint management controls.
• Support New Product Development by ensuring quality requirements and risk assessments.
• Direct supplier qualification and supplier quality improvement programs.
• Participate in safety, training, operational excellence, and cost improvement initiatives.
• Maintain and improve the Quality Management System and regulatory documentation.
• Perform additional duties to support objectives.

Skills

Bilingual

Problem-solving

Project management

Analytical

Communication

Decision-making

Education

Bachelor's Degree in Engineering General

Job description

STERIS is seeking a Quality Systems Manager to lead the quality management system, ensuring regulatory compliance and robust quality processes across development, manufacturing, and distribution. The role oversees audits, CAPA, supplier quality, and continuous improvement initiatives to meet customer and business expectations.

Responsibilities include leading the quality team, maintaining ISO/FDA/MDSAP compliance, and driving quality improvements across the product lifecycle.