Teams at FITS LLC

Leads engineering design delivery for large capital projects in pharmaceutical, biotech, warehouse, or logistics facilities. Establishes design standards and requirements, coordinates multidisciplinary design teams and A/E firms, manages design reviews and schedules, ensures regulatory and project-intent compliance, resolves design issues, tracks earned-value progress, and drives design efficiency improvements.

Develops and maintains quality standards for medical device manufacturing. Collaborates with engineering and manufacturing teams, designs inspection and testing methods, conducts quality assurance testing, performs statistical analysis, investigates nonconformances, supports validation and risk assessments, and ensures corrective actions and documentation meet reliability and compliance requirements.

Ensures suppliers deliver compliant, high-quality parts, materials, and services for medical device manufacturing. The role qualifies and monitors suppliers, resolves supplier-related quality issues, evaluates supplier performance, supports supplier changes, develops acceptance sampling strategies and control plans, coordinates approved supplier activities, and validates receiving inspection test methods. It partners with R&D, sourcing, engineering, operations, and quality teams to prevent defects and drive continuous improvement.