Bob H.

Senior Quality Engineer @Integra LifeSciences

Cincinnati, OH, US

Senior Quality Engineer – Sustaining Quality Engineering Support for Integra Life Science’s Stereotactic (Brain Mapping) and CUSA (Tissue Ablation)product lines; also New Product development for the next generation of the tissue ablation(Clarity)Feb 2014 to PresentResponsibilities include:• Leads in the prompt implementation of Non-Conformance resolution, complaint investigations and Corrective & Preventative Action(s)(CAPA support).• Facilitates the launching of new or improved products/processes from a Quality perspective. • Develops statistically based sampling plans required for in-process, final testing/inspections, and validations.• Create and maintain design and process FMEA’s.• Ensures that all projects are in compliance with GMP’s, QSR (including Design Controls), ISO and/or other applicable regulatory requirements.• Formulates detailed product quality plans based on need and using risk analysis.• Supports the Quality Management Review Process.• Participates in FDA inspections, ISO Certification and surveillance and customer audits.• Perform internal and supplier Audits for compliance with corporate and international regulatory guidelines.• Interacts and coordinates activities with external vendors to resolve product nonconformance and ensuring delivery to schedule.• Works with Product Development teams to ensure all aspects of Design Transfer activities are being achieved.• Aids in the implementation of SPC control system with Manufacturing and Quality Control.

IWU

Bachelor of Art, Business

IWU

Bachelor of Applied Science (B.A.Sc.), Business Administration, Management and Operations