Experiences at Kerma Medical Products

Official Correspondent for the FDA.
Responsible for maintaining compliance with FDA CGMP (21 CFR 820).
Customer complaint resolution and providing excellent customer service to customers, vendors and other departments.
Trained and supervised quality control inspectors.
Process auditing and analysis, receiving and final inspection of medical device manufacturing, repackaging and relabeling.
Writing, updating and implementing Quality System Procedures, Work Instructions and company Quality Manual.
Evaluating and taking corrective action as necessary within all areas of production.
Researching and completing Corrective and Preventive Action Requests.
Resolving Quality Issues and Non-Conforming Material Reports.
Tracking Customer Complaint metrics and working as a team to reduce complaints and associated costs.
Responsible for company-wide safety programs.
Customer correspondence....