Senior Manager, Quality Systems

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

Position Summary

The Quality Systems Manager is responsible for leading and maintaining the organization's Quality Management System, ensuring compliance with applicable regulatory requirements and international quality standards. This role oversees quality assurance processes, regulatory compliance, supplier quality, audits, customer complaint management, and new product development quality activities. The position provides leadership to the quality team, drives continuous improvement initiatives, and ensures products are developed, manufactured, and distributed in compliance with applicable regulations while meeting customer and business expectations. Additionally, the role promotes operational excellence through the implementation of best practices in quality management and regulatory compliance.

Duties

• Lead and develop the Quality team, providing guidance, coaching, and performance support.
• Ensure compliance with applicable quality and regulatory standards, including ISO, FDA, MDSAP, EU MDR, and NOM requirements.
• Own and lead Management Review activities, serving as the site Quality Management Representative.
• Drive continuous improvement initiatives through data analysis, CAPA management, problem-solving methodologies, and quality performance monitoring.
• Oversee production, environmental, process, supplier, and complaint management controls to ensure product quality and customer satisfaction.
• Support New Product Development activities by ensuring quality requirements, risk assessments, manufacturability, reliability, and compliance requirements are met.
• Direct supplier qualification and supplier quality improvement programs based on risk and performance assessments.
• Participate in safety, training, operational excellence, and cost improvement initiatives across the organization.
• Maintain and continuously improve the Quality Management System and associated procedures, records, and regulatory documentation.
• Perform additional duties as assigned to support business and compliance objectives.

Education Degree

• Bachelor's Degree in Engineering General

Required Experience

• Bilingual
• 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.
• roven leadership experience managing technical and quality-focused teams.
• Strong problem-solving, project management, analytical, communication, and decision-making skills.Preferred certifications include CQE, CQA, CQMgr, Lean, or Six Sigma.

Preferred Experience

• Advanced degrees or Quality Certifications: CQE, CQA, CQMgr., Six Sigma or Lean

STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention. WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare and life sciences products and services around the globe. For more information, visit www.steris.com.

STERIS strives to be an Equal Opportunity Employer.