Sterility Assurance Specialist

Sterility Assurance Specialist - 6 months contract Switzerland

New opportunity has opened up in a sterility department for a global medical devices company.

The project involves the following tasks:

▪ Review, maintain and develop procedures tools and methodologies to cover all Sterility Assurance programs

▪ Ensure compliancy to new MDR, (MDD), ISO 13485, ISO 14971, ISO 9001 and FDA (QSR) regulations and 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 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.

Requirements:

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

Proficiency with the Microsoft Office Suite is required.

Proven knowledge and ability regarding product verification and process

Please send your CV