Analise Wojciechowski

Biomedical Engineer with experience supporting quality, validation, and manufacturing activities in FDA-regulated medical device environments. Skilled in IQ/OQ/PQ validation, CAPA support, root cause analysis, controlled documentation, dimensional inspection, and statistical data analysis. Experienced in cross-functional problem solving and applying risk-based methods to improve product and process quality.

Engineering Intern at Medisurge (2022-05 – 2024-12)

• Supported validation, quality, and manufacturing activities for medical devices in an FDA-regulated contract manufacturing environment.
• Executed IQ/OQ/PQ validation protocols for manufacturing processes and medical device products, documenting results and verifying that established requirements were met.
• Supported CAPA and manufacturing investigations using root cause analysis and data analysis, including identifying and addressing operator assembly variation through fixture implementation and clarified work instructions.
• Authored and maintained controlled documentation including work instructions, validation protocols, component specifications, engineering change orders, and inspection records.
• Performed equipment qualification, calibration, and dimensional inspection to support validated manufacturing processes and verify compliance with product and process requirements.
• Collaborated with engineering, quality, manufacturing, and customers to support new product launches, validation activities, manufacturing discussions, and resolution of technical issues.
• Supported ISO 11607 medical device packaging validation through seal integrity, leak, and tensile testing.
• Wrote technical justification supporting an FDA submission for revised tensile strength requirements following a medical device design change.

Bachelor of Science in Engineering in Biomedical Engineering – Grand Valley State University (2026-05)