Sr Quality Manager

Confidential Jobs; Monterrey; Presencial; MXN 900.000 - 1.300.000; Jornada completa

Descripción de la vacante

Confidential Jobs in Monterrey, Mexico seeks an experienced Quality Manager to lead and support the implementation of quality policies, procedures and standards across the organization. You will collaborate with Operations, Engineering, Supply Chain, Manufacturing and other teams to drive quality initiatives, maintain QMS, and ensure regulatory compliance.

The role requires 5–8 years of progressive quality experience, leadership skills, and strong problem-solving abilities to drive continuous

Formación

• Bachelor's degree in Engineering, Quality, Manufacturing, Industrial Engineering, Life Sciences, or a related technical field required.
• Master's degree preferred.
• Minimum of 5-8 years of progressive experience in Quality Assurance, Quality Systems, or Manufacturing Quality, with prior leadership or supervisory experience preferred.
• Experience in a regulated manufacturing environment preferred.
• Experience with ISO 9001, ISO 13485, IATF 16949, or similar quality standards preferred.
• Equivalent combinations of education and experience will be considered.

Responsabilidades

• Lead and support the implementation of quality policies, procedures, and standards across the organization.
• Establish departmental objectives and performance metrics aligned with business goals.
• Collaborate with Operations, Engineering, Supply Chain, Manufacturing, and other teams to drive quality initiatives and improvements.
• Provide guidance on quality evaluations, control systems, nonconforming products, customer concerns, regulatory requirements, and product reliability.
• Prepare and present quality performance reports to management and customers as required.
• Serve as a primary quality contact for customer inquiries, audits, escalations, and quality-related requirements.
• Maintain and improve quality management systems in compliance with customer, industry, and regulatory requirements.
• Develop and maintain procedures for inspection, testing, validation, and evaluation of products and manufacturing processes.
• Utilize statistical methods and quality tools to analyze quality performance, identify trends, and implement corrective and preventive actions.
• Manage internal and external quality audits, ensuring timely resolution of findings and effective corrective actions.
• Ensure quality documentation is accurate, complete, and compliant with applicable standards and regulatory requirements.
• Drive continuous improvement initiatives focused on process effectiveness, product quality, customer satisfaction, and operational excellence.
• Lead, coach, and develop Quality Engineers, Quality Supervisors, and other quality personnel as required.
• Ensure compliance with applicable quality certifications and standards, including ISO 9001, ISO 13485, IATF 16949, and other relevant regulatory requirements.
• Support New Product Introduction (NPI) activities by ensuring appropriate quality planning, risk assessments, and validation activities are completed.
• Review and approve quality system documentation, validation protocols, control plans, procedures, work instructions, and other quality-related records.
• Ensure validation activities and quality processes comply with applicable regulatory and customer requirements.
• Promote a culture of quality, accountability, and continuous improvement throughout the organization.
• Perform other duties as assigned.

Conocimientos

Leadership

Cross-functional collaboration

Quality management

Communication

Problem solving

Strategic thinking

Project management

Data analysis

Team development

Auditing

Educación

Bachelor's degree

Master's degree

Descripción del empleo

• Lead and support the implementation of quality policies, procedures, and standards across the organization.
• Establish departmental objectives and performance metrics aligned with business goals.
• Collaborate with Operations, Engineering, Supply Chain, Manufacturing, and other functional teams to drive quality initiatives and improvements.
• Provide guidance and solutions related to quality evaluations, control systems, nonconforming products, customer concerns, regulatory requirements, and product reliability.
• Prepare and present quality performance reports to management and customers as required.
• Serve as a primary quality contact for customer inquiries, audits, escalations, and quality-related requirements.
• Maintain and improve quality management systems in compliance with customer, industry, and regulatory requirements.
• Develop and maintain procedures for inspection, testing, validation, and evaluation of products and manufacturing processes.
• Utilize statistical methods and quality tools to analyze quality performance, identify trends, and implement corrective and preventive actions.
• Manage internal and external quality audits, ensuring timely resolution of findings and effective implementation of corrective actions.
• Ensure quality documentation is accurate, complete, and compliant with applicable standards and regulatory requirements.
• Drive continuous improvement initiatives focused on process effectiveness, product quality, customer satisfaction, and operational excellence.
• Lead, coach, and develop Quality Engineers, Quality Supervisors, and other quality personnel as required.
• Ensure compliance with applicable quality certifications and standards, including ISO 9001, ISO 13485, IATF 16949, and other relevant regulatory requirements.
• Support New Product Introduction (NPI) activities by ensuring appropriate quality planning, risk assessments, and validation activities are completed.
• Review and approve quality system documentation, validation protocols, control plans, procedures, work instructions, and other quality-related records.
• Ensure validation activities and quality processes comply with applicable regulatory and customer requirements.
• Promote a culture of quality, accountability, and continuous improvement throughout the organization.
• Perform other duties as assigned.

Qualifications

Knowledge, Skills, and Abilities

• Strong leadership and team management skills.
• Excellent verbal and written communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Knowledge of quality management systems, auditing methodologies, and continuous improvement tools.
• Experience with root cause analysis, CAPA, statistical analysis, and problem-solving methodologies.
• Proven ability to build effective cross-functional relationships.
• Strong organizational, analytical, and decision-making skills.
• Demonstrated success in driving process improvements and achieving quality objectives.
• Ability to work effectively in a collaborative and matrixed environment.

Education & Experience Requirements

• Bachelor's degree in Engineering, Quality, Manufacturing, Industrial Engineering, Life Sciences, or a related technical field required.
• Master's degree preferred.
• Minimum of 5-8 years of progressive experience in Quality Assurance, Quality Systems, or Manufacturing Quality, with prior leadership or supervisory experience preferred.
• Experience in a regulated manufacturing environment preferred.
• Experience with ISO 9001, ISO 13485, IATF 16949, or similar quality standards preferred.
• Equivalent combinations of education and experience will be considered.