Experience

Erba Lachema s.r.o.

• Czechia
• Biotechnology Research
• 1 - 100 Employee

• Quality Manager

  • Jul 2018 - Present

  Site quality management representative leading quality team responsible for site quality assurance, quality control, supplier quality and quality engineering in production of IVD diagnostic instruments and reagents. Quality system certified based on ISO 13485 and IVDR legislation. Responsibility for solving of customer complaints, internal nonconformities, CAPA, change management, risk management and post market surveillance. Supplier management and audits responsibility. Site quality management representative leading quality team responsible for site quality assurance, quality control, supplier quality and quality engineering in production of IVD diagnostic instruments and reagents. Quality system certified based on ISO 13485 and IVDR legislation. Responsibility for solving of customer complaints, internal nonconformities, CAPA, change management, risk management and post market surveillance. Supplier management and audits responsibility.



oncomed manufacturing a.s.

• Okres Brno-město, Česká republika

• Project manager

  • Feb 2016 - Jun 2018

  Leading of projects in quality (FDA preparation, quality supervising) and process optimization area (process mapping and realization of process optimization projects in manufacturing). Leading of projects in quality (FDA preparation, quality supervising) and process optimization area (process mapping and realization of process optimization projects in manufacturing).



Teleflex

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

• Quality Engineering Manager

  • Aug 2013 - Jan 2016

  Responsibility for quality system with certification according to ISO 13485 and FDA certification in factory for production of medical devices for intensive care, urology, anesthesia and surgery care class II and III. Responsibility for ensuring compliance with MDD 93/42/EEC, CFR part 21, ISO 13485 and corporate standards. Responsibility for documentation system in English language, change management, risk management, creation of labeling, solving of customer complaints, non-conformance and CAPA systems. Participation on research & development and engineering activities. Leading of department with 8 employees. Show less

• Quality Manager

  • Oct 2009 - Jul 2013

  Responsibility for quality system with certification according to ISO 13485 in factory for production of medical devices for urology, anesthesia and surgery care class II and III. Organization and leading of certification and customer audits. Responsibility for ensuring compliance with MDD 93/42/EEC, ISO 13485 and corporate standards. Responsibility for documentation system in English language, change management, internal audits, creation of labeling, solving of customer complaints, set up of non-conformities and CAPA systems. Participation on research and engineering activities. Leading of department with 3 employees. Show less



PLIVA-Lachema a.s.

• Head of Technological department

  • Sep 2007 - Sep 2009

  Working in manufacturing plant for oncology care drugs. Responsibility for technology on all plants (production of injections, production of oral solid forms - tablets, production of API, packaging). Responsibility for creation of all production documentation. Working according GMP and cGMP. Participation on audits from state authorities and FDA. Participation on investment projects - isolator technology. Head of department with 10 employees. Responsibility for budgetary control of department. Working in manufacturing plant for oncology care drugs. Responsibility for technology on all plants (production of injections, production of oral solid forms - tablets, production of API, packaging). Responsibility for creation of all production documentation. Working according GMP and cGMP. Participation on audits from state authorities and FDA. Participation on investment projects - isolator technology. Head of department with 10 employees. Responsibility for budgetary control of department.