Quality Manager (ISO 13485)`

North American Production Sharing de México, S.A. de C.V.; Tijuana; Presencial; MXN 546.000 - 819.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Weekly salary

Benefits above legal requirements

Major medical insurance

Life insurance

Savings fund

Additional company benefits

Descripción de la vacante

North American Production Sharing de México, S.A. de C.V. is seeking a Quality Assurance Manager (ISO 13485) to lead QA, calibration, and document control in our manufacturing facility in Tijuana.

You will drive the QMS, ensure regulatory conformance, and foster a culture of quality excellence. The role requires at least 7 years in QA with leadership, bilingual English/Spanish, and experience with regulated medical device manufacturing.

Formación

• 7+ years of experience in Quality Assurance with leadership responsibilities.
• Bilingual in English and Spanish.
• Experience leading QA/QC teams within a regulated manufacturing environment.
• Strong knowledge of ISO 13485 including implementation, auditing, and regulatory compliance.

Responsabilidades

• Lead the establishment, implementation, and continuous improvement of the Quality Management System (QMS).
• Ensure medical devices meet quality, regulatory, and conformity requirements prior to product release.
• Direct and enhance QA and QA/QC processes across manufacturing operations.
• Oversee incoming materials, production processes, and final product release with traceability and non-conformity management.
• Lead supplier quality programs including qualification, monitoring, and GMP/QMS audits.
• Manage Document Control and Training programs to ensure regulatory and quality compliance.
• Develop and execute training strategies, providing leadership and performance coaching for the Quality team.

Descripción del empleo

Quality Assurance Manager (ISO 13485)

The Quality Assurance Manager is responsible for leading and overseeing all Quality Assurance activities within the manufacturing facility, ensuring compliance with regulatory requirements, quality standards, and customer expectations. This role provides strategic and operational leadership to the Quality organization, including QA, Calibration, and Document Control functions, while driving a culture of continuous improvement and quality excellence.

Main Responsibilities

• Lead the establishment, implementation, maintenance, and continuous improvement of the Quality Management System (QMS).
• Ensure medical devices meet all applicable quality, regulatory, and conformity requirements prior to product release.
• Direct and enhance Quality Assurance and Quality Control processes across manufacturing operations.
• Oversee quality activities related to incoming materials, production processes, and final product release, ensuring traceability, compliance with specifications, and effective management of non-conformities.
• Lead supplier quality management programs, including qualification, monitoring, and GMP/QMS audits.
• Manage Document Control and Training programs to ensure compliance with regulatory and quality requirements.
• Develop and execute training strategies while providing leadership, coaching, and performance management for the Quality team.

• Minimum 7 years of experience in Quality Assurance, including leadership and management responsibilities.
• Bilingual (English/Spanish).
• Experience leading QA/QC teams within a regulated manufacturing environment.
• Experience in the Medical Device industry strongly preferred.
• Strong experience in developing, implementing, and maintaining Quality Management Systems (QMS).
• Mandatory knowledge of ISO 13485, including implementation, maintenance, auditing, and regulatory compliance.
• Knowledge of QMSR, FDA regulations, GMP, and applicable medical device regulatory requirements.

Benefits:

• Weekly salary
• Benefits above legal requirements
• Major medical insurance
• Life insurance
• Savings fund
• Additional company benefits

Location: Pacific Industrial Park, Tijuana.