Quality Manager

Westfall Mexico S.A de C.V.; Tijuana; Presencial; MXN 1,119,000 - 1,494,000; Jornada completa

Descripción de la vacante

A manufacturing firm in Tijuana is seeking a Quality Manager to oversee the Quality Management System and ensure compliance with industry standards. The ideal candidate will have at least 7 years of experience in quality disciplines and proven leadership in a managerial role. Responsibilities include managing quality audits, developing production processes, and leading a quality team. Competitive salary and a focus on continuous improvement are offered.

Formación

• At least 7 years of experience in a quality discipline, including 5 years in a managerial role.
• Thorough knowledge of plastic injection molding and assembly processes.
• Leadership experience in an injection molding environment preferred.

Responsabilidades

• Establish, monitor, and maintain the Quality Management System.
• Conduct internal quality system audits.
• Lead and develop the quality team.

Conocimientos

Leadership experience

Strong technical writing

Effective communication

Proficiency in Excel and statistical software

Mechanical aptitude

Commitment to zero defects

Organizational skills

Focus on continuous improvement

Educación

Bachelor's degree in Engineering, Quality, or Science

Herramientas

ISO 13485

ISO 14971

AIAG VDA FMEA

Statistical software

Descripción del empleo

Quality Manager Job Description

Establish, monitor, and maintain the Quality Management System, applying continuous improvements.

Knowledge and demonstrated compliant application of the Quality System Regulations, ISO 13485, ISO 14971, AIAG VDA FMEA, hazard analysis, fault tree analysis, and pFMEA.

Develop and ensure compliance of production and process controls, risk management plans, product-specific quality plans, and control strategies. Execute these through clear quality procedures and records, utilizing good documentation principles.

Ensure all commitments in customer quality agreements are understood and met by relevant teams.

Manage change control activities in compliance, especially for changes requiring customer notification or approval.

Establish sampling plans, develop, and validate production processes and test methods with documented capability.

Complete first article reports for new molds, including full dimensional evaluations as required by local and customer standards.

Lead, train, and develop the quality team; collaborate internally and externally to ensure product safety, efficacy, and quality.

Conduct internal quality system audits in accordance with medical device, automotive regulations, and local QMS.

Ensure efficient workflow of product inspections across all shifts.

Maintain quarantine areas and product disposition processes to prevent use of nonconforming products.

Perform other duties as assigned.

Qualifications

• Bachelor's degree in Engineering, Quality, or Science, with at least 7 years of experience in a quality discipline, including 5 years in a managerial role.
• Thorough knowledge of plastic injection molding and assembly processes.
• Strong technical writing and review skills.
• Leadership experience in an injection molding environment preferred.
• ASQ certifications such as Certified Quality Manager or Certified Quality Auditor preferred.
• Knowledge of ISO 14644/cleanroom and IATF 16949 is a plus.
• Understanding of environmental health and safety regulations.
• Proficiency in Excel, Access, Word, and statistical software.
• Strong mechanical aptitude and organizational skills.
• Effective team leadership and communication skills.
• Ability to operate inspection equipment.
• Commitment to zero defects and overall customer satisfaction.
• Ability to meet deadlines and prioritize tasks effectively.
• Focus on continuous improvement and maintaining a neat, organized department.