Description
STERILITY ENGINEER SPECIALIST (QA)An innovative company, which is one of the largest international Medical Device manufacturers worldwide, is currently seeking a Sterility Engineer. The position will be for a period of 6 months (good possibility of extension).
POSITION DUTIES & RESPONSIBILITIES:
- This position is responsible for implementation and management of sterility assurance and reprocessing cleaning. This position ensures compliance to the applicable FDA (QSR) regulations, Medical Device Directive (MDD), ISO 13485, ISO 14971 and ISO 9001 as they apply to sterilization and reprocessing cleaning.
- This position provides Sterility Assurance (SA), oversight to ensure the adequacy of these activities and documentation in terms of regulatory compliance and technical soundness throughout manufacturing system.
- Establish and maintain procedures, tools and methodologies to cover all SA programs
- Maintain knowledge of FDA & ISO sterilization
- Conduct technical assessments of contract sterilizers and laboratories
- Ensure sterility validations for all product families are maintained
- Ensure timely and complete sterilization adoptions and validations of all new products.
- Review all vendor sterility assurance validation protocols and reports
- Collaborate with corporate packaging and validation groups to ensure a comprehensive approach to bring new/changed products into production.
PROFESSIONAL EXPERIENCE REQUIREMENTS:
- Minimum 2 years sterilization/microbiological experience in the medical device and/or pharmaceutical industry
- Knowledgeable in applicable FDA (QSR) regulations, Medical Device Directive (MDD), ISO13485, ISO 14971 and ISO 9001.
- Well versed in government regulations and industry guidelines for sterilization (i.e. ISO/EN/AAMI standards) and microbiological control of medical devices.
- Fluent in English and German
EDUCATIONAL REQUIREMENTS:
- BS Degree in Microbiology, Biological Sciences or Engineering
You can expect a challenging and varied job in a multicultural environment. If this is something you are interested in please send your CV to Ms Sarah Tomasella, If you have any questions please feel free to contact us on . We look forward to hearing from you.