Sterilization Expert

Sterilization expert/ 100% Home Office THE POSSIBILITY OF TRAVELING TO THE USA

You need:
Minimum Bachelor's Degree in Biology, Microbiology, Chemistry, Biochemistry or equivalent

4 years of work experience in Design Assurance, Regulatory Affairs, R&D or Quality Experience with the sterilization functional area: EO, Y/E-beam, Wet, Reprocessing, Chemical, Aseptic, Plasma, etc. and/or biocompatibility, pharmacological, animal origin, resorbable or experience in nanomaterials.

Activities:
Perform conformity assessments of regulatory submissions, such as design files and technical documentations, against safety principles and relevant standard requirements.

Perform regulatory audits of clients according to the European Medical Device Directives (AIMD, MDR, IVDR), the Single Audit Program for Medical Devices (USA, Canada, Brazil, Japan, Australia) and international quality system standards (eg ISO 13485), as well as internal standards

Project Management:
Providing project management for NAFTA-based clients.

Project management potentially consists of issuing quotes, coordinating multiple projects, coordinating the audit team, and answering customer questions.

Evolution, standards and service capabilities of TÜV SÜD America through internal training sessions, external seminars and reading of scientific articles.

Tipo de puesto: Tiempo completo

Salario: $75,000.00 al mes

Tipo de jornada:

- Turno de 8 horas

Pregunta(s) de postulación:

- Contar con visa