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:
- At least 7 years of experience in Quality Assurance with 3 years of experience as a manager.
- 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.
Location: Parque Industrial Pacífico.
Job Type: Full-time
Pay: $1.00 - $2.00 per month
Application Question(s):
- Are you able to have a fluent conversation in English?
- Do you have a valid visa to travel to the US?
- Have you previously worked with ISO 13485?
- Are you or have you been the lead in ISO audits?
Work Location: In person
