standards of care. The Engineering Controls and Documentation Manager is responsible for overseeing Integra’s engineering... project and capital execution controls, policies, procedures, and equipment and facility life cycle documentation. The role...
standards of care. SUMMARY DESCRIPTION The Senior Manager of the Tissue Technology (TT) Design Assurance Engineering... department is responsible for developing Design Assurance Engineering resources, processes, and tools required to design, develop...
. The role involves ensuring system readiness through documentation review, contributing to program development... and calibration, ensuring compliance with data integrity, and maintaining inspection-ready documentation through collaboration. The...
in quality from the start, embedding QMSR/820 design controls, CLIA/CAP, IVDR, ISO13485, and 21 CFR 11 across lab operations... Documentation Practices (GDP) and ALCOA/ALCOA+ across sample, method, and data lifecycles; steward validated LIMS/ELN records...