**Position Summary** Responsible for providing strategic and hands\-on quality leadership across manufacturing, validation, supplier management, and continuous improvement activities to ensure product safety, effectiveness, and regulatory compliance with the Quality Management System (QMS), FDA 21 CFR Part 820, ISO 13485, and other global regulations. **Key Responsibilities** **Manufacturing \& Process Quality** * Ensure appropriate validation activities are executed and maintained (IQ/OQ/PQ, process validation, equipment qualification). * Lead investigations related to non\-conformances, deviations, and CAPAs using risk\-based methodologies. * Support PFMEA/DFMEA activities and risk management per ISO 14971\. **Complaint Handling \& Post\-Market Surveillance** * Oversee complaint handling, trending, and escalation processes. * Ensure timely reporting of adverse events (e.g., MDRs, vigilance reporting) when applicable. **Quality Management System (QMS)** * Develop, implement, maintain, and continuously improve the Quality Management System in compliance with FDA, ISO 13485, and applicable international regulations. * Ensure effective document control, record retention, and change management (ECR/ECO). **Regulatory \& Compliance** * Ensure compliance with FDA 21 CFR Part 820, ISO 13485, ISO 14971, and other applicable standards. * Serve as the primary quality representative during FDA inspections, ISO audits, and customer audits. **Supplier Quality Management** * Establish and maintain supplier qualification, monitoring, and audit programs. * Ensure supplier compliance with quality and regulatory requirements. **Leadership \& People Management** * Lead, coach, and develop quality team members. * Foster a culture of quality, compliance, and continuous improvement. **Continuous Improvement** * Drive quality improvements using data\-driven metrics (yield, DPPM, CAPA effectiveness). * Promote risk\-based decision making throughout the organization. **Education** * Bachelor’s degree in Engineering, Life Sciences, Quality, or a related field (Master’s preferred). **Experience** * 7\+ years of quality experience in the medical device, pharmaceutical, or regulated healthcare industry. * 3\+ years in a quality leadership or management role. * Direct experience with FDA inspections and ISO 13485 audits. * Strong background in manufacturing quality and validation. **Skills \& Competencies** * In\-depth knowledge of FDA 21 CFR Part 820 and ISO 13485\. * Strong understanding of risk management (ISO 14971, FMEA). * Problem\-solving, root cause analysis skills \& hands\-on issue solving. * Effective written and verbal communication. * Strong leadership and stakeholder management skills. * Ability to balance compliance, risk, and business objectives. **Preferred Certifications** * ASQ Certified Quality Manager (CQM) * ASQ Certified Quality Engineer (CQE) * Lean Six Sigma (Green Belt or Black Belt) **Working Conditions** * May require occasional travel for customer visits. * Manufacturing and cleanroom environments required. Tipo de puesto: Tiempo completo Sueldo: A partir de $13,000\.00 al mes Beneficios: * Caja de ahorro * Estacionamiento de la empresa * Opción a contrato indefinido * Seguro de vida * Servicio de comedor * Vales de despensa Lugar de trabajo: Empleo presencial