- 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.

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📌 Sr Quality Manager (Monterrey)
🏢 Confidential Jobs
📍 Monterrey