Nelson Lapnet

Responsible for collaborating with suppliers to ensure timely delivery and regulatory compliance. Conducts audits, First Article Inspections, and oversees validation documentation for Non-Verifiable Processes. Provides quality input for FDA responses and assists in developing innovative solutions for new medical devices.

Supervised supplier nonconformances, designed test protocols for regulatory compliance, and collaborated with design teams for new product development. Conducted advanced data analyses to identify quality improvements.

Oversaw Quality Assurance deliverables from design to commercialization, performed supplier audits, and guided compliance with REACH and RoHS directives. Initiated corrective actions and led continuous improvement activities.

Developed and implemented tutoring plans for students, provided private instruction, and coordinated with instructors to enhance students' critical thinking skills.

Managed software quality and compliance, maintained Design History Files, and led the development of Product Risk Management Plans. Provided support in product development using quality engineering techniques.

Created and approved Risk Assessments, managed sterilization and packaging validations, and investigated operational problems affecting production. Presented Quality System metrics to senior management.

Developed testing methods and quality procedures, performed root cause analysis, and supported product development stages. Assisted in creating engineering documentation.

Completed a Master of Science in Biomedical Engineering, focusing on advanced topics in the field and gaining hands-on experience in medical device development and validation.

Earned a Bachelor of Science in Biomedical Engineering, covering foundational principles and practices in biomedical engineering and preparing for a career in the medical device industry.