Ing de Calidad (experiencia en ensamble de medical devices)

Requirements (Education & Experience)

• Bachelor’s degree in engineering or a related technical field.
• 3 plus years of experience in the medical device industry or other regulated environments.
• 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.
• Fluent in English and Spanish (written and verbal).

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.