Job Title: Manufacturing Engineer Experience: 5+ years Location: Ponce, Puerto Rico
Overview: Responsible for developing, optimizing, and maintaining manufacturing processes to ensure efficient production and high-quality products.Responsible for ensuring that manufacturing processes meet quality standards and compliance with regulatory guidelines.
Key Responsibilities: Design and implement manufacturing processes for new and existing products. Lead process improvement initiatives to enhance productivity and reduce costs. Troubleshoot and resolve production-related issues. Conduct process validations (IQ/OQ/PQ) and ensure equipment readiness. Develop and maintain manufacturing documentation. Develop, implement, and maintain quality processes and systems. Perform root cause analysis and corrective actions for quality-related issues. Conduct audits to ensure compliance with ISO and FDA standards. Collaborate with engineering and production teams to improve product quality. Oversee non-conformance management, CAPA, and complaint investigations. Support the validation of processes, equipment, and systems. Monitor and analyze key quality metrics to identify improvement areas. Collaborate with quality and operations teams to support compliance activities. Monitor key performance indicators (KPIs) and drive continuous improvements. Qualifications: Bachelor's degree in Engineering or related field. 5+ years of experience in manufacturing engineering. Experience with CAPA, NCR, and quality management systems (QMS). Knowledge of FDA and ISO regulations. Strong attention to detail with excellent communication skills. Expertise in lean manufacturing and process optimization. Experience with process validation and equipment commissioning. Strong knowledge of manufacturing standards (ISO, FDA).