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.

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📌 Quality Engineer (Medical Devices Assembly experience required) (Tijuana)
🏢 OFERTA CONFIDENCIAL
📍 Tijuana