Quality Engineer Medical Devices Experience

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.