Since 1990 I have worked with quality assurance, training, measurement, calibration and validation, and contributed to the design, creation, implementation and maintenance of effective quality management systems, both within the private and public sectors.

In 1998 I received certificate as Lead Auditor, registered by the International Register of Certificated Auditors (UK), IRCA reg. no. A 2166)

Since I have worked as Auditor and carried out audits of business processes within companies and at suppliers and subcontractors.

My skills are primarily obtained from international companies within medical and electronic mechanical devices and IT and telecom Industry. I have been involved in projects and quality management, preparation of procedures, complaint handling (CAPA), audits, analysis and mapping of processes, education and Development.

Responsible for contact to customers, suppliers and partners at home and abroad.

International standards, EU directives and FDA / GMP regulations and legislation have always been the focus for ensuring compliance and fulfillment of applicable requirements prior to certification and in connection with the application for product approval prior to launch.

Core competencies: QA/QC/RA; GMP/GLP; FDA CFR 21 Part 820; LEAN; CAPA; KAIZEN

• Quality, project and risk management
• Design, development and maintenance of management systems
• Audit and optimization of business processes
• Change Management  (KAIZEN & LEAN)
• Coaching, teaching, management and communication
• Use of international standards as effective management tools