Biocompatibility Specialist
Jasmin Baumgartner is recruiting for a Biocompatibility Specialist to join a company in the medical device industry at their site based in Oberdorf on a 1-year contract basis.
The main purpose of the role will be to:
Implement biological safety evaluations of medical devices according to ISO 10993, including gap assessment activities
Work with site staff to locate and review present product documentation in respect to Biocompatibility, Manufacturing Processes, Sterilization, Packaging and/or Cleaning Validation information
Work together with associates of varied technical backgrounds and partner with Regulatory Affairs, Quality Engineering, Manufacturing, Packaging and Project Teams, to achieve desired project outcomesFurther responsibilities will include:
Ensure all testing meets the ISO, FDA, CDRH, and GLP requirements
Compile and write Biocompatibility Test Plan, Test Report and Risk Assessment
Understand and identify possible gaps for ISO 10993-1 and supporting ISO 10993 testing where needed.
In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
Master's degree in chemistry, biochemistry, biology or similar- Medical Device knowledge and understanding of MDR regulations and ISO 10993 standards is a plus
Written and verbal communication skills German and English is essential
This is an excellent opportunity to join a global company.
For more information or to apply for this position, please contact Jasmin Baumgartner on 0041 (0) 782 508 535 or email jbaumgartner@ckqls.ch. Please quote reference 45433 in all correspondence.
