Sterility Assurance Specialist - medical devices
We have a new opening for a Sterility Expert to support the Quality Assurance department in development of sterility programs and processes.
▪ 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), ▪ 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.
Position Requirements and Qualifications:
A Bachelor of Science Degree is required. A Master of Science or PhD is preferred.
Minimum of 5 years experiences in support of medical devices 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.
Well known with critical design features for clinical reprocessing
This is 12 months contract based on site in Switzerland
Michael Bailey International is acting as an Employment Business in relation to this vacancy.