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) 3 years of continuous experience in the medical device industry. 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, 5 S, SMED, Kanban, VSM, Poka-Yoke). Collaborative approach when working with Engineering, Production, and other departments. #J-18808-Ljbffr

📌 Quality engineer (medical devices assembly experience required) (Centro-Norte)
🏢 OFERTA CONFIDENCIAL
📍 Centro-Norte