Quality Manager (ISO 13485)
About the role
Quality Manager (ISO 13485)
The Quality 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.
Ensure compliance with FDA regulations, GMP requirements, and international quality standards applicable to medical devices.
Requirements
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, and additional company benefits.
Location: Pacific Industrial Park, Tijuana.
Job Type: Full-time
Work Location: In person
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