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Sterility Assurance Specialist
Eingestellt von Experis AG
Gesuchte Skills: Design, Support
Projektbeschreibung
STERILITY ASSURANCE SPECIALIST
Experis IT is Europe's leading IT&T recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across several professional sectors, with IT being at the heart of our operations.
On behalf of our client, one of the WORLD'S LEADING MEDICAL DEVICE COMPANIES, located in ZUCHWIL SO, Switzerland we are looking for a DESIGN QUALITY ENGINEER
This is a CONTRACTING position from the 25TH OF JUNE UNTIL THE END OF THIS YEAR.
YOUR TASKS:
- Review, maintain and develop procedures tools and methodologies to cover all Sterility Assurance programs
- Responsible for the European Sterility Assurance activities.
- Ensure 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 (esp. EN ISO EN ISO 15883, EN ISO 17665, EN ISO 17664), AAMI standards/reports (eg AAMI TIR 12 and 30) and other guidance documents as required.
- Maintain knowledge of FDA & ISO sterilization guidelines and Johnson & Johnson standard.
- Evaluate gamma-, ethylene oxide- and moist heat- sterilization processes for existing products and compliancy to new MDR requirements.
- Develop and evaluate cleaning, disinfection and steam sterilization processes for existing and new products.
- Review and evaluate reprocessing strategies and processes for new MDR
- Validate all microbial aspects of existing products
- Ensure the development and implementation of harmonized practices/procedures.
- Review external validation protocols and reports to ensure Synthes and regulatory requirements are met.
- Implement the microbial assurance aspects of the Quality System.
- Review and analyze medical device drawings
- Actively support our compliance program and related initiates or activities.
WHAT YOU BRING TO THE TABLE:
- BACHELOR OF SCIENCE or equivalent work experience
- 5+ YEARS OF EXPERIENCE in support of Medical Device's delivery, biology, pharmaceutical or similar regulated industry
- Proven knowledge of FDA AND MDD GMP requirements or standards regarding medical Devices
- Experience with GMP environments, particularly sterilization processes, microbiological testing
- Knowledge of critical design features for clinical reprocessing
- Proficiency with the Microsoft Office Suite
- ENGLISH language proficiency
IT WOULD BE A PLUS IF YOU ALSO HAVE:
- Master of Science or PhD
- German language proficiency
LOCATION: Zuchwil SO, Switzerland
If you are a result oriented person who is currently looking for an exciting new position the job description applies to your skills, then we look forward to receiving your application!
If you aren't sure whether you should apply or have any questions, please call Nastasia Whyte.
Experis IT is Europe's leading IT&T recruitment agency. We are dedicated to connecting talented individuals with Business opportunities across several professional sectors, with IT being at the heart of our operations.
On behalf of our client, one of the WORLD'S LEADING MEDICAL DEVICE COMPANIES, located in ZUCHWIL SO, Switzerland we are looking for a DESIGN QUALITY ENGINEER
This is a CONTRACTING position from the 25TH OF JUNE UNTIL THE END OF THIS YEAR.
YOUR TASKS:
- Review, maintain and develop procedures tools and methodologies to cover all Sterility Assurance programs
- Responsible for the European Sterility Assurance activities.
- Ensure 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 (esp. EN ISO EN ISO 15883, EN ISO 17665, EN ISO 17664), AAMI standards/reports (eg AAMI TIR 12 and 30) and other guidance documents as required.
- Maintain knowledge of FDA & ISO sterilization guidelines and Johnson & Johnson standard.
- Evaluate gamma-, ethylene oxide- and moist heat- sterilization processes for existing products and compliancy to new MDR requirements.
- Develop and evaluate cleaning, disinfection and steam sterilization processes for existing and new products.
- Review and evaluate reprocessing strategies and processes for new MDR
- Validate all microbial aspects of existing products
- Ensure the development and implementation of harmonized practices/procedures.
- Review external validation protocols and reports to ensure Synthes and regulatory requirements are met.
- Implement the microbial assurance aspects of the Quality System.
- Review and analyze medical device drawings
- Actively support our compliance program and related initiates or activities.
WHAT YOU BRING TO THE TABLE:
- BACHELOR OF SCIENCE or equivalent work experience
- 5+ YEARS OF EXPERIENCE in support of Medical Device's delivery, biology, pharmaceutical or similar regulated industry
- Proven knowledge of FDA AND MDD GMP requirements or standards regarding medical Devices
- Experience with GMP environments, particularly sterilization processes, microbiological testing
- Knowledge of critical design features for clinical reprocessing
- Proficiency with the Microsoft Office Suite
- ENGLISH language proficiency
IT WOULD BE A PLUS IF YOU ALSO HAVE:
- Master of Science or PhD
- German language proficiency
LOCATION: Zuchwil SO, Switzerland
If you are a result oriented person who is currently looking for an exciting new position the job description applies to your skills, then we look forward to receiving your application!
If you aren't sure whether you should apply or have any questions, please call Nastasia Whyte.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Sonstiges