Sterility Assurance Specialist in Zuchwil
Jocelyn Blackham is recruiting for a Sterility Assurance Specialist to join a global leader in the medical device field at their site based in Solothurn on a contract basis for 12 months, with the possibility of extension.
The main purpose of the role will be to:
- Review, maintain and develop procedures tools and methodologies to cover all Sterility Assurance programs.
- Ensure compliance to new MDR.
- Ensure 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 (e.g. AAMI TIR 12 and 30) and other guidance documents as required.
- Maintain knowledge of FDA & ISO sterilization guidelines and company 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.
- Ensure the development and implementation of harmonized practices/procedures.
- Implement the microbial assurance aspects of the Quality System.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- A Bachelor of Science Degree is required. A Master of Science or PhD is preferred.
- Previous experience 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.
- Proficiency with the Microsoft Office Suite is required.
This is an excellent opportunity to join a global leader within the medical device field.
For more information or to apply for this position, please contact Jocelyn Blackham on +41 (0) 417276793 or email jblackham@ckqls.ch. Please quote reference QLS44041 in all correspondence.