Strategic QA Leader (ISO 13485) for Medical Devices

North American Production Sharing De México, S.A. De C.V.; Tijuana; On-site; MXN 546,000 - 819,000; Full time

Benefits offered by this job

Weekly salary

Benefits above legal requirements

Major medical insurance

Life insurance

Savings fund

Additional company benefits

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Job description

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.