Quality Engineer — Med Device, ISO Regulated, 3–6 yrs

Oferta confidencial; Tijuana; Presencial; MXN 502.200 - 837.000; Jornada completa

Descripción de la vacante

Oferta confidencial is seeking a Quality Engineer to lead quality initiatives across cross-functional projects in a regulated environment. You will drive IQ/OQ/PQ validations, contribute to FMEA-based risk management, and support documentation updates for manufacturing processes.

Key qualifications include English/Spanish fluency, 3–6 years in medical devices or similar industries, ISO 13485/14971 knowledge, and strong Excel/database skills.

Formación

• Fluent in English and Spanish (written and verbal).
• 3 to 6 years of experience in the medical device industry or other regulated environments.
• Experience from automobile or aerospace manufacturing is a plus.
• Bachelor’s degree in engineering or related technical field.
• Strong knowledge of ISO 13485, ISO 14971, and regulatory frameworks (FDA QSR preferred).
• Experience with IQ/OQ/PQ process validation.
• Proficiency in statistical analysis and data-driven decision-making.
• Advanced skills in Microsoft Excel, databases, and documentation tools.

Responsabilidades

• Represent 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.

Conocimientos

Fluent in English and Spanish

Root cause analysis

Statistical analysis

Process validation (IQ/OQ/PQ)

Lean manufacturing tools

Cross-functional collaboration

Educación

Bachelor’s degree in engineering or related technical field

Herramientas

Microsoft Excel

Databases

Documentation tools

Descripción del empleo

Oferta confidencial is seeking a Quality Engineer to lead quality initiatives across cross-functional projects in a regulated environment. You will drive IQ/OQ/PQ validations, contribute to FMEA-based risk management, and support documentation updates for manufacturing processes.

Key qualifications include English/Spanish fluency, 3–6 years in medical devices or similar industries, ISO 13485/14971 knowledge, and strong Excel/database skills.