пропозиції роботи
Ewelina Chorłowska
Vigilance Director SW
Poznań,
wielkopolskie
Dołącz do GoldenLine i obejrzyj pełny profil tej użytkowniczki
Zobacz pełny profil
Języki
angielski
biegły
Doświadczenie zawodowe
Inżynier Jakości / Quality Engineer
Responsibilities:
- ISO 13485 requirements implementation and improvement
- assurance of conformity with ISO standards, Directives and FDA requirements for Medical Devices
- creation and verification of QMS procedures
- customer processes requirements implementation (FMECA and Control Plans)
- production supervision (FMECA, Control Plans, procedures, instructions, participation in process validation, corrective and preventive actions, stability plans, statistical analysis)
- customer claims and deviations supervision
- customer and certification audit participation
- quality supervision for infrastructure – quality assurance and validation (room systems – production clean rooms and laboratory area, environmental control system, local exhaust ventilation system)- GMP requirements implementation (procedures, garments, trainings)
- ISO 13485 requirements implementation and improvement
- assurance of conformity with ISO standards, Directives and FDA requirements for Medical Devices
- creation and verification of QMS procedures
- customer processes requirements implementation (FMECA and Control Plans)
- production supervision (FMECA, Control Plans, procedures, instructions, participation in process validation, corrective and preventive actions, stability plans, statistical analysis)
- customer claims and deviations supervision
- customer and certification audit participation
- quality supervision for infrastructure – quality assurance and validation (room systems – production clean rooms and laboratory area, environmental control system, local exhaust ventilation system)- GMP requirements implementation (procedures, garments, trainings)
Szkolenia i kursy
„Medical Device Package Design, Protection & Testing Methods” - MEDICO Industrien (Certyfikat)
„FDA Requirements for Medical Devices” – Beatrice Salis, CfPA (Certyfikat)
"Dokumentacja techniczna dla wyrobów medycznych (CE), analiza ryzyka" - TUV Nord (Certyfikat)
"Dyrektywa wyroby medyczne 93/42/EEC z uwzględnieniem zmian zaplanowanych na lata 2008-2010 - wymagania" (Certyfikat)
"Wymagania normy ISO 13485, techniki audytowania" - CEMED (Certyfikat audytora wewnętrznego ISO 9001 oraz ISO 13485)
„FDA Requirements for Medical Devices” – Beatrice Salis, CfPA (Certyfikat)
"Dokumentacja techniczna dla wyrobów medycznych (CE), analiza ryzyka" - TUV Nord (Certyfikat)
"Dyrektywa wyroby medyczne 93/42/EEC z uwzględnieniem zmian zaplanowanych na lata 2008-2010 - wymagania" (Certyfikat)
"Wymagania normy ISO 13485, techniki audytowania" - CEMED (Certyfikat audytora wewnętrznego ISO 9001 oraz ISO 13485)
Edukacja
Biotechnologia, magisterskie
Akademia Rolnicza im. Augusta Cieszkowskiego w Poznaniu
Specjalizacje
Zarządzanie jakością
Zapewnienie jakości
Zainteresowania
Hodowla dogów niemieckich oraz storczyków domowych.
Organizacje
15.01.2008 – 18.04.2008 – „Eden Springs”, Quality Specialist
Responsibilities:
- product quality assurance
- product microbiological and physicochemical control
- production supervision
- implementation and improvement of HACCP system (procedures, self-inspections, GMP)
01.12.2006 – 19.04.2007 - „GlaxoSmithKline”, Quality Assurance Specialist
Responsibilities:
- periodical product review
- production supervision (aerosols, ointments) – characteristics and documentation control
- production statistical analysis and reports
- deviations and corrective actions (single cases)
01.09.2006 – 31.11.2006 - „GlaxoSmithKline”, student assistance (Quality Assurance)
Responsibilities:
- periodical product review
Responsibilities:
- product quality assurance
- product microbiological and physicochemical control
- production supervision
- implementation and improvement of HACCP system (procedures, self-inspections, GMP)
01.12.2006 – 19.04.2007 - „GlaxoSmithKline”, Quality Assurance Specialist
Responsibilities:
- periodical product review
- production supervision (aerosols, ointments) – characteristics and documentation control
- production statistical analysis and reports
- deviations and corrective actions (single cases)
01.09.2006 – 31.11.2006 - „GlaxoSmithKline”, student assistance (Quality Assurance)
Responsibilities:
- periodical product review
