Quality Engineer (Medical Devices Assembly experience required)

Oferta confidencial; Tijuana; Presencial; MXN 420.000 - 650.000; Jornada completa

Descripción de la vacante

Oferta confidencial is seeking a Sr. Quality Engineer in Tijuana, Mexico to lead quality initiatives, coordinate cross-functional projects, and ensure compliance with medical device standards.

The role focuses on process validation, documentation, and continuous improvement with strong attention to detail. Ideal candidates will have medical device experience, English/Spanish fluency, and hands-on knowledge of IQ/OQ/PQ, ISO 13485/14971, and Lean tools.

Formación

• Bachelor’s degree in engineering or related technical field.
• 3 years in the medical device industry.
• Fluent in English and Spanish.
• Strong knowledge of ISO 13485 and ISO 14971; FDA QSR preferred.
• Experience with IQ/OQ/PQ and process validation.
• Proficient in 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

Quality mindset

Root cause analysis

Cross-functional teamwork

Data-driven decision-making

Lean manufacturing

Educación

Bachelor's degree in engineering

Herramientas

Excel

Databases

Documentation tools

Descripción del empleo

Sr. Quality Engineer

Top 5 Key Responsibilities

• 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.

Requirements (Education & Experience)

1. 3 years of continuous experience in the medical device industry.
2. Fluent in English and Spanish (written and verbal).

• Bachelor’s degree in engineering or a related technical field.
• Strong knowledge of ISO 13485, ISO 14971, 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 & Competencies

• Strong 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.