Hvidovre, Capital Region of Denmark, Denmark
The thrill when a corrective action is being implemented gives me a kick. I have extensive experience and is dedicated to quality assurance, control and inspection. I have the knowledge and skills to solidly found and run a QEMS. I - point out the best places to invest in better quality - implement the changes - provide the foundation of a solid and sound profit, Specialties: Metrology, Quality Management, Internal audit. LEAN implementation, Business Process Reengineering, Supplier cooperation, Calibration, Education and sharing knowledge
Managing the team of 7 metrology operators and 6 quality control inspectors. The department does QC and QA measurements and supervision of operators inspections on injection molded plastic parts for the medical devise industry. Activities covered and certified by ISO 13485, ISO 9001, ISO 14001 as well as customer specific requirements.
Qualification of production of flexible wound care dressing. Gluing, laminating, punching, sorting, silicone molding, inspection, testing, packing and documenting of theese processes as part of the production optimization. Working 12 hour night and occasionally day shifts Working in the medical device industry covered by the ISO 13485 and ISO 9001 standards
Updating of the QMS Implementation of corrective actions Planing, execution and follow-up on internal audits Reporting, handling, follow-up and closure of corrective actions reports. Management of the standards library