- 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