Operational Excellence

Strategic supplier qualification validates partners against regulatory and quality requirements.

Inventory management balances material availability with cost efficiency for production continuity.

Global sourcing strategies identify alternate suppliers to mitigate single-source vulnerabilities.

Digital tracking systems maintain component traceability from raw materials through finished devices.

Comprehensive project planning aligns resources with critical path activities to maintain schedules.

Regular milestone reviews provide transparency and early identification of potential challenges.

Risk management processes anticipate and mitigate issues before they impact timelines.

Cross-functional collaboration integrates engineering, quality, regulatory, and manufacturing expertise throughout development.

Risk assessment identifies critical process parameters to preserve during facility transitions.

Parallel validation activities minimize production disruptions during transfer implementation.

Comprehensive documentation ensures knowledge transfer between sending and receiving sites.

Cross-functional transfer teams coordinate activities across quality, engineering, and operations.

Six Sigma DMAIC process validates all critical manufacturing processes to >1.33 Cpk capability standards.

Layered Process Audit (LPA) systems ensure consistent quality oversight throughout production.

Comprehensive certification programs paired with 100% non-destructive testing.

In-house automation technology enables high-speed inspection capabilities of up to 12 parts per second.