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Sterility Assurance Specialist (Sterilization for Medical Device, GMP
Eingestellt von Randstad (Schweiz) AG
Gesuchte Skills: Client, Design
Projektbeschreibung
Randstad Professionals (Schweiz) is currently looking for an experienced STERILITY ASSURANCE SPECIALIST for a 6 months assignment in Switzerland.
Our client is a major name in the Medical device industry. A specialist with experience in the MDD/MDR and focus on the cleaning and stezilization ISO/EN standarts is currently needed.
DESCRIPTION:
- Review, maintain and develop procedures tools and methodologies to cover all Sterility Assurance programs
- Responsible for the European Sterility Assurance activities and compliancy to new MDR
- Ensures compliance to the applicable Medical Device Directive (MDD), ISO 13485, ISO 14971, ISO 9001 and FDA (QSR) regulations as they apply to sterilization. Additionally, to other applicable Cleaning and Sterilization ISO and EN standards (EN ISO 15883/17665/17664), AAMI standards/reports (eg AAMI TIR 12 and 30) and other guidance documents as required.
- Maintain knowledge of FDA & ISO sterilization guidelines
- Develop and evaluate cleaning, disinfection and steam sterilization processes for existing and new products.
- Ensure the development and implementation of harmonized practices/procedures.
- Review external validation protocols/reports to ensure regulatory requirements are met.
- Implement the microbial assurance aspects of the Quality System.
- Review and analyze medical device drawings
REQUIREMENTS AND EXPECTATIONS:
- Bachelor of Science or equivalent work experience
- 5+ YEARS OF EXPERIENCE IN MEDICAL DEVICE'S, biology, pharmaceutical or similar regulated industry
- Proven knowledge of FDA and MDD GMP requirements
- Experience with GMP environments, sterilization processes, microbiological testing
- Knowledge of critical design features for clinical reprocessing
Fluency in English is mandatory and GERMAN IS A VALUABLE ASSET - spoken and written.
If you are interested for this great role, don't hesitate to get in touch with me. I am looking forward to receiving your applications
Olivier Worch
Randstad Professionals (BASEL Office)
(see below)
Our client is a major name in the Medical device industry. A specialist with experience in the MDD/MDR and focus on the cleaning and stezilization ISO/EN standarts is currently needed.
DESCRIPTION:
- Review, maintain and develop procedures tools and methodologies to cover all Sterility Assurance programs
- Responsible for the European Sterility Assurance activities and compliancy to new MDR
- Ensures compliance to the applicable Medical Device Directive (MDD), ISO 13485, ISO 14971, ISO 9001 and FDA (QSR) regulations as they apply to sterilization. Additionally, to other applicable Cleaning and Sterilization ISO and EN standards (EN ISO 15883/17665/17664), AAMI standards/reports (eg AAMI TIR 12 and 30) and other guidance documents as required.
- Maintain knowledge of FDA & ISO sterilization guidelines
- Develop and evaluate cleaning, disinfection and steam sterilization processes for existing and new products.
- Ensure the development and implementation of harmonized practices/procedures.
- Review external validation protocols/reports to ensure regulatory requirements are met.
- Implement the microbial assurance aspects of the Quality System.
- Review and analyze medical device drawings
REQUIREMENTS AND EXPECTATIONS:
- Bachelor of Science or equivalent work experience
- 5+ YEARS OF EXPERIENCE IN MEDICAL DEVICE'S, biology, pharmaceutical or similar regulated industry
- Proven knowledge of FDA and MDD GMP requirements
- Experience with GMP environments, sterilization processes, microbiological testing
- Knowledge of critical design features for clinical reprocessing
Fluency in English is mandatory and GERMAN IS A VALUABLE ASSET - spoken and written.
If you are interested for this great role, don't hesitate to get in touch with me. I am looking forward to receiving your applications
Olivier Worch
Randstad Professionals (BASEL Office)
(see below)
Projektdetails
Geforderte Qualifikationen
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Kategorie:
IT Entwicklung, Medien/Design