As a Quality Assurance professional, I develop and implement quality assurance policies, procedures, and processes to ensure consistent quality across products and services. I evaluate and manage supplier quality, ensuring materials and components meet specifications. I conduct regular internal audits to identify improvement areas and ensure compliance with quality standards and regulations. I stay current with industry regulations and lead continuous improvement initiatives using tools like Lean Six Sigma. Additionally, I provide training on quality topics to foster a culture of continuous improvement and monitor customer feedback to enhance satisfaction.

In this position, I developed and implemented a comprehensive Quality Management System, authored and updated quality procedures, and coordinated training programs for engineering and quality teams. I managed corrective and preventative actions, nonconformances, and change control records, and led efforts to evaluate nonconformances. My role included ensuring compliance through equipment validation and calibration, auditing client-contracted facilities for industry standards compliance, and supporting internal and external audits to maintain ISO 9001:2015 certification. Additionally, I acted as a subject matter expert on quality systems for external clients and maintained a regulatory standards database, communicating updates effectively.

In my previous role, I translated client needs into innovative designs for new facilities, equipment, and systems, conducted fact-finding surveys, and developed comprehensive project concepts. I managed and supervised domestic and international engineering projects, overseeing subcontractors for specialized components. My responsibilities included organizing project logistics, such as purchasing and supply chain management, and collaborating closely with vendors and manufacturers to ensure project success.

At Amgen, I was pivotal in managing project resources, tracking department budgets, and overseeing the Transport Simulation lab. I led Thermal Packaging Engineering's project management and business processes, supporting project initiation and prioritization while conducting update meetings. I managed change controls, nonconformance, and CAPA records, and implemented communication plans to align vendors and internal teams. Additionally, I delivered monthly Thermal Packaging reports to executive management, launched and maintained the department’s website, and was proficient in EDM Quality for document management. I also developed a Qualification Process VSM to improve communications, acted as a liaison between Amgen engineers and external vendors, and trained new engineers and temporary staff.

At National Genetics, I was responsible for conducting a wide range of laboratory tests and analyses, ensuring accuracy and compliance with established protocols. Skilled in operating and maintaining sophisticated laboratory equipment and managing data within Laboratory Information Management Systems (LIMS). Known for a strong commitment to quality control, safety, and continuous improvement.