Quality Manager

Medline Industries; Nuevo Laredo; Presencial; MXN 1,284,000 - 1,652,000; Jornada completa

Descripción de la vacante

A leading healthcare supplier located in Nuevo Laredo is seeking a quality management specialist with over 5 years of experience. The ideal candidate will have extensive knowledge in ISO 13485, FDA regulations, and GMP standards. Key responsibilities include developing quality standards, overseeing product compliance, and conducting audits. This role demands strong leadership and effective communication skills in a bilingual environment.

Formación

• 5+ years of experience in Quality Management Systems.
• Extensive knowledge of ISO 13485, FDA, and GMP.
• Experience in Six Sigma and Lean Manufacturing.

Responsabilidades

• Design, implement, and improve quality standards.
• Inspect final output against requirements.
• Ensure effective implementation of the Quality Management System.

Conocimientos

Fluent in English

Leadership

Customer Focus

Attention to detail

Effective Communication

Problem Solving

Educación

Bachelor's degree in engineering or related field

Herramientas

MS-Project

MS-Visio

ERP / AS400 Information Generation Systems

Descripción del empleo

Responsibilities

• Understand the needs and requirements of the customer and communicate them along with the quality standards to the production teams.
• Design, improve, and review new specifications and procedures for products or processes, and train staff on their use.
• Establish the requirements for raw materials from suppliers and control their compliance.
• Oversee product development procedures to identify any deviations from quality standards.
• Inspect the final output, compare it to the requirements, and approve or reject the final products.
• Maintain accurate documentation and perform statistical analysis.
• Obtain feedback from customers, attend meetings, present reports, and assist external auditors and inspectors.
• Design, implement, and improve the company\'s quality standards.
• Formulate strategies to increase productivity.
• Review processes to ensure they align with current trends.
• Work with the multidisciplinary group to determine action plans and short-term goals that allow for the achievement of annual objectives.
• Build alliances and partnerships with the multifunctional groups from other sites.
• Coordinates and advises on Corrective and Preventive Action projects.
• Ensures the effective implementation of the Quality Management System.
• Maintains the schedule of external audits, reports results, and ensures timely follow-up on findings.

Education

• Bachelor\'s degree in engineering or related field.

Work Experience

• At least 5+ years of experience in the Quality Management Systems
• Extensive Knowledge in ISO 13485, FDA and GMP
• Knowledge of Continuous Improvement and Lean Manufacturing Methodologies
• Experience in Six Sigma and Lean Manufacturing.

Knowledge / Skills / Abilities

• Bilingual (Fluent in English)
• Knowledge as an Internal Auditor under ISO13485
• Knowledge in interpreting design drawings and diagrams.
• MS-Project, MS-Visio, ERP / AS400 Information Generation Systems.
• Leadership
• Customer Focus
• Result Oriented
• Attention to detail
• Effective Communication
• Problem Solving

Medline Industries, LP is an equal opportunity employer. Medline evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.