Certification of substance based medical devices, borderline products (medical device/drug), combination products (medical device/drug) in over 50 countries worldwide (e.g. CE, MENA, Brazil, USA, China), preparation of technical documentation, biocompatibility, risk management, rationalization of technical documentation, vigilance, qualified person medical devices, QM/RA contracts and due diligance, supplier audits, internal audits, QMS optimization, process automation

Deputy Head of QA/QC. Leading certification and competent authority audits. Supplier audits. Validation of new factory implants class III with focus on FDA compliance. Qualification and cleaning validation. Responsibility CAPA, Change Control, QA contracts, Complaints a.o. for class III MDs. Rationalization and automation of QM processes with the help of ERP system (MS Navision), JET reports or Excel macros. Assuring compliance according to ISO 13485, ISO 9001 and GMP. Support in 510(k) and CE… Show more Deputy Head of QA/QC. Leading certification and competent authority audits. Supplier audits. Validation of new factory implants class III with focus on FDA compliance. Qualification and cleaning validation. Responsibility CAPA, Change Control, QA contracts, Complaints a.o. for class III MDs. Rationalization and automation of QM processes with the help of ERP system (MS Navision), JET reports or Excel macros. Assuring compliance according to ISO 13485, ISO 9001 and GMP. Support in 510(k) and CE submissions. Show less

Quality assurance of active medical implants (defibrillators, pacemakers) and external medical devices (e.g. external pacemakers). Development accompanying responsibility and moderation of FMEAs (design development + process development). Design of a risk management system and the implementation and validation of RM software.