Cartago, Costa Rica
Organized and dependable Engineer with extensive experience in supplier quality engineering, quality assurance and complaint investigation. Successful at managing multiple priorities with a positive attitude. Skilled in working under pressure and adapting to new situations and challenges to best enhance the organizational results. Results-oriented with problem-solving and critical thinking skills, as well as meticulous attention to detail and methodical nature. Skilled in tackling problems in unique ways to develop innovative solutions. Consistently recognized by superiors and peers for expertise and forward-thinking mindset. Talented to guide all functions related to studies, research, analysis, and reports. Bringing a disciplined, resourceful, and results-oriented approach to all functions withing IQA, Complaints and SQE areas.
As the primary Quality Engineer during second shift operations in a Class III medical device manufacturing facility, I am responsible for ensuring quality compliance and operational integrity during off-hours. My role involves providing direct, hands-on support to the production floor, including the resolution of nonconformities, investigation of deviations, root cause analysis, and coordination of timely product release. I take full ownership of all quality-related matters that arise during the night shift, serving as the lead decision-maker when senior daytime staff are unavailable. I work closely with cross-functional teams—including Manufacturing, Engineering, Microbiology, and Incoming Quality Assurance—to implement containment actions and drive corrective initiatives. My responsibilities also include monitoring, documenting, and escalating critical events, while preparing comprehensive shift-end summaries to ensure continuity and visibility for leadership. I actively participate in both internal and external audits, ensuring that all documentation and on-shift activities comply with regulatory and customer requirements. Additionally, I manage NCRs, CAPAs, and deviation reports, contributing to continuous improvement efforts. My scope of work mirrors that of daytime Quality Engineers, helping to maintain consistency, compliance, and seamless quality operations across all shifts.
As a Supplier Quality Engineering Specialist and Lead Auditor, I was instrumental in establishing the Supplier Quality Engineering Department, defining processes, and developing training protocols. I managed supplier relationships, handled change projects, and facilitated communication with internal departments. I also created data integration tools for dashboards to aid in decision-making. In my auditing role, I led supplier audits for ISO 13485, 17025, and 9001 standards, identifying improvements and implementing corrective actions. I planned and executed audits, traveled to supplier sites for inspections, and evaluated audit findings through interviews and observations. As an Incoming Inspection and Quality Assurance Specialist, I helped create the Incoming Inspection Department, designed protocols, selected equipment, and ensured compliance with ISO standards. I supervised quality assurance activities, reducing inspection backlogs and resolving quality issues through coordination with suppliers and internal teams. I also developed inspection procedures, conducted root cause analyses, and trained staff on quality standards. I participated in over 11 external audits, handling documentation, coordinating with departments, and resolving compliance issues. I acted as the main contact for auditors, ensuring smooth communication and access to necessary records. In the Complaints Department, I managed customer complaints by evaluating samples, conducting risk assessments, and reviewing Device History Records. I defined root causes, coordinated resolutions, and implemented corrective actions. I also improved complaint data handling and created dashboards for better insights. Overall, my experience spans Supplier Quality Engineering, Incoming Inspection, External Audits, and Complaints Management, demonstrating a strong commitment to quality, continuous improvement, and effective communication in the medical device industry.
Support research and development to create new products. Collaborate with leadership team to identify relevant questions and determine solutions. Process data for implementation in the design of mechanical components for research projects. Preparation of reports, presentations and scientific papers.
Collaborate with management, technical team members and supervisors to organize efficient operations on the site and achieve objectives. Inspect machinery and equipment to diagnose malfunction. Using power and hand tools and specialized equipment to complete work and repairs safely and accurately.