Sr.
Quality EngineerTop 5 Key ResponsibilitiesRepresent Quality in cross-functional projects, ensuring compliance with regulatory and internal quality standards.Support process verification and validation activities (IQ/OQ/PQ), including documentation and reporting.Collaborate in the development and update of manufacturing documentation, including procedures, work instructions, and risk management (e.G., FMEA).
Analyze manufacturing issues and non-conformities to identify root causes and drive continuous improvement actions.Support supplier quality activities (audits, validations, changes) and participate in internal and external audits.Requirements (Education & Experience)3 years of continuous experience in the medical device industry.Fluent in English and Spanish (written and verbal).
Bachelor's degree in engineering or a related technical field.Strong knowledge of ISO *****, ISO *****,



and regulatory frameworks (FDA QSR preferred).
Experience with process validation methodologies (IQ/OQ/PQ).
Proficiency in statistical analysis and data-driven decision-making.Advanced skills in Microsoft Excel, databases, and documentation tools.Key Skills & CompetenciesStrong attention to detail and organizational skills.Effective communication skills (written and verbal).
Ability to work both independently and within cross-functional teams.Problem-solving mindset with a focus on root cause analysis.Customer/patient-focused quality mindset.Experience in Lean Manufacturing tools (Kaizen, 5S, SMED, Kanban, VSM, Poka-Yoke).
Collaborative approach when working with Engineering, Production, and other departments.
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📌 Quality Engineer (Medical Devices Assembly Experience Required) (Tijuana)
🏢 Importante Empresa Del Sector
📍 Tijuana