- Fluent in English and Spanish (written and verbal).
- 3 to 6 years of experience in the medical device industry or other regulated environments. preferably.
- We can also consider candidates coming from the automobile and aerospace manufacturing industry.
- Bachelor’s degree in engineering or 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.

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📌 Quality Engineer (Medical devices Experience) (Tijuana)
🏢 Empresa líder
📍 Tijuana