Position Summary The Senior Manager, Quality is responsible for leading quality improvement for complex or multi-site manufacturing or service facilities. This position takes the lead in developing, adopting and maintaining state-of-the-art quality practices for sites which have multi-faceted product/service lines and associated regulatory requirements. The Senior Manager, Quality assumes overall responsibility in ensuring that the site maintains operational and quality systems in a state of compliance to domestic and international standards. The role is responsible for the organization, documentation and maintenance of the quality system to be compliant with, as appropriate, the following standards: ISO 9001, ISO 13485, MDSAP and FDA 21 CFR Part 820/211, EU MDR, NOM-241-SSA1, QSMR and other applicable standards. This role leads the local site(s) efforts focused on product/service quality improvement, supplier quality, process quality, new product/service development quality and quality system compliance. The Senior Manager, Quality serves as the Management Representative for the site(s) and is responsible for ensuring the quality system meets all applicable regulatory standards. 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
• 10-15 years of combined Manufacturing/Quality Engineering and/or Quality Systems experience.
• 10-15 years of experience working in an ISO certified environment required.
• Minimum of 6 years in a Quality leadership role.
• Droven 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.
• 10-15 years of experience with medical device or other regulated industries preferred. Preferred Experience
• Advanced degrees or Quality Certifications: CQE, CQA, CQMgr., Six Sigma or Lean.
• ASQ, QSR or familiarity with QSR/GMP regulations preferred. STERIS is a leading general 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.

📌 Senior Manager, Quality (Isla Guadalupe)
🏢 STERIS Mexico de C.V. (Operations
📍 Isla Guadalupe