•Review all incoming RMAs for assigned product lines and facilitate disposition with the appropriate department. Coordinate the evaluation, documentation and close out of all complaints.
•Lead a weekly review session to discuss assigned product line RMAs and determine priorities for corrective action and customer follow up. Review RMA trends and initiate RCCAs as needed.
•Conduct continuous assessment audits to ensure continued compliance with QMS requirements.
•Assist with training in the business unit and satellite facilities to ensure personnel are familiar with and knowledgeable regarding QMS requirements..
•Assist in the RCCA (Root Cause Corrective Action) System for BioMedical Products and Processes.
•Assemble and lead cross-functional teams for assigned product lines to accurately diagnose root cause, recommend corrective actions, and verify the effectiveness of the action taken.
•Establish, maintain and track the appropriate measurements of external quality (warranty, RMA, RCCA, defects, etc) for assigned product lines. Work with management to develop a monthly PPM report.
•Work with Management to develop and monitor BioMedical Quality Objectives and goals.
•Working knowledge and experience with ISO 13485 Quality Systems practices
•Outstanding communication skills at all levels (written and verbal)
•Proven ability to work with cross-functional teams and in a project management environment
•Experience with J.D. Edwards or similar system.
•Strong analytical skills for evaluating quality data.
•Demonstrated ability to plan and manage multiple tasks/projects
•BS degree required