QA Manager

The Quality Assurance Manager (QA Manager) in Tijuana oversees the daily operation of the Quality area in support of the company's production plant. This includes supervising the QA, Calibration, and Document Control teams, ensuring compliance with policies, procedures, and Good Manufacturing Practices (cGMP).

Main Responsibilities

• Ensure the establishment, implementation, and continuous maintenance of quality processes according to the requirements of the Quality Management System.
• Ensure that medical devices comply with conformity requirements before release.
• Manage and continuously improve QA and QC processes for production lines.
• Oversee quality assurance and control processes during material reception, production, and product release, ensuring traceability, specification compliance, and non-conformity management.
• Manage the supplier control program, including GMP/QMS audits.
• Administer Document Control and Training programs.
• Develop training plans and provide daily work instructions to personnel under supervision.

Requirements:

• Relevant degree.
• At least 7 years of experience in Quality Assurance.
• Bilingual.
• Previous experience managing QA/QC functions and teams.
• Experience in medical device manufacturing (preferred).
• Knowledge in the development and implementation of comprehensive quality management systems (QMS).
• Knowledge of: QMSR, ISO 13485, FDA Guidelines, GMP.

Benefits:

• Weekly salary, benefits above the legal requirements, major medical insurance, life insurance, savings fund, and additional benefits.

Location: Pacific Industrial Park.