Experience

Diatron Medical Instruments

• Hungary
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Head of Quality

  • Jan 2018 - Present

• Quality Manager

  • Mar 2017 - Dec 2017



ThalesNano Inc.

• Hungary
• Chemical Manufacturing
• 1 - 100 Employee

• Technical Operations Director

  • Aug 2015 - Mar 2017

  • Lead the following departments: Production, Logistics, Quality and Warehouse (Managing 11 staff)• Ensure cost effective operation of the company: production planning and its alignment to sales, inventory management and reduction, identification and management of cost reduction activities• Ensure robust quality management system by establish the following quality functions: SQA, QS, incoming and finished product QC. Implement metrics and feedback system• Continuously evaluate the effectiveness of the departments and manage improvement activities using LEAN tools with special focus on logistics (base data, procurement, shipping, production planning and stock accuracy)



BD

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Production Quality Leader

  • Jun 2013 - Aug 2015

  • Led the following Quality functions: Production Quality Engineering, Batch Release, Microbiology, Quality Control: Incoming Material Control and Finished Product Control (Managing 46 staff)• Ensured efficiency of PQA functions by analyzed, challenged and improved their performance• Continuously monitored and improved the quality management processes of the different production areas• Ensured compliance with ISO 9001, ISO 13485, FDA and relevant cGMP regulations



Coloplast

• Denmark
• Medical Equipment Manufacturing
• 700 & Above Employee

• Senior SQA Manager

  • May 2012 - May 2013

  • Ensured compliance to national/international quality standards of supplier processes• Quality approval of suppliers: Performed audits, negotiated and approved quality agreements• Managed improvements tasks/projects at suppliers• Managed/reviewed CAPA including root cause analysis on Supplier related tasks and gave input to STC Quality• Designed, reviewed and updated of SQM Key processes in connection with changes to existing materials, intermediates and products and ensured these were aligned with related areas and company business• Specialist level on Supplier Quality Management, audit types (including link to business and ethic and decision board) and acted as mentor for other global supplier specialists in the organization and transfered knowledge by training

• Head of Quality

  • May 2010 - May 2012

  • Overall responsibility for quality and regulatory compliance of the Nyírbátor Site according to the corporate and international quality standards• Ensured that the quality system supports the business development and efficiency of the Site• Led the following Quality functions: Operative Quality Engineering, Validation, Microbiology, Incoming Material Control, Customer Complaints Handling, EHS, Supplier Quality Assurance (Managing 22 staff)

• Head of Operations

  • Jul 2009 - May 2010

  • Led the Nyírbátor Site’s manufacturing and warehouse functions (6 Value Streams) so that all production activities met the organization’s business objectives and were conducted in accordance with the relevant health & safety, environmental and quality standards• Contributed to strategic planning and decision-making at Site management level• Monitored the cost and effectiveness of production activities to optimize resources, prioritize spending and achieve volume, quality and manufacturing standards

• Quality Leader

  • Nov 2007 - Jul 2009

  • Established the quality management system from the beginning of the operation at the Site according to the corporate quality standards• Led the Operative Quality Engineering and Validation functions• Hired the Quality staff• Provided support for successful incoming transfers from quality point of view• Quality support for production processes

• Quality Engineer

  • Aug 2004 - Nov 2007

  • Kept continuous control and improved the quality management processes of the Value Stream• Ensured compliance with ISO 9001, ISO 13485, FDA and Japanese regulations• Issued, updated and distributed quality instructions and forms• Organized quality training• Handled quality related activities of machine and process transfers from Denmark• Investigated customer complaints and took corrective and preventive actions• Analyzed and evaluated non-conformities



Gedeon Richter - PregLem S.A.

• Switzerland
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Plant mechanical engineer

  • Jul 2001 - Aug 2004

  • Organized and controlled maintenance activities; SAP PM module• Kept contact with suppliers in connection with maintenance projects• Assumed responsibility for qualification documentations of machines and supply systems

• Validation Engineer

  • Sep 1998 - Jul 2001

  • Established the system of verification of HVAC systems for clean rooms• Performed validation activities of HVAC system of clean rooms and laminar air flow units, nitrogen and compressed air supply systems