Sterility Assurance Coordinator

Sterility Assurance Coordinator

Randstad Professionals are one of the leading recruitment companies in Switzerland and with a dedicated IT contracting team in Zurich. We are excited to help you in your search. We focus on finding the best contracts for the best contractors.

We are looking for a Sterility Assurance Coordinator for our client based in Solothurn.

Responsibilities:
This position is located in the department Sterility Assurance to support Sterility Assurance Specialist/Manager in documentation and testing.
This position is responsible to ensure the efficient flow and processing of new and/or changed documentation into, within and outside of the department.
This position is responsible for the sterility assurance sampling process flow to process samples to the laboratories/suppliers.
This position ensures compliance to the applicable Medical Device Directive (MDD), ISO 13485.

Detailed description:
Coordinate the receipt of incoming documents into the Switzerland department. Ensure that the incoming documents are filled out or created correctly. When there are issues, work with Product Development (PD) or Sterility Assurance Team Members to ensure they are performing the proper corrections. Follow up with them and communicate released document status to them. Ensure the communicated project timelines can be met.
Create change request/orders for documents to update them based on Sterility Assurance Specialist decision.
Give direction to Product Development, Regulatory, and manufacturing facilities regarding sterility assurance documentation questions.
Create and maintain department database.
Coordinate frequently sterility assurance testing as well as validations/studies with the laboratory/supplier starting from the order until receiving the report.
Other duties/responsibilities as assigned by manager.

Skills:
This position requires a high level of written and oral communication skills
Working knowledge of applicable software, particularly Microsoft Office applications.
Excellent organizational skills.
Language: English and Swiss German spoken and written

Education and professional experience:
Successful completed apprenticeship (eg KV, medical assistant)
Professional experience for at least 2 year

Whether this role is the right fit or you would like to see if there are others that do, our dedicated and expert team is looking forward to hearing from you.

Good to know you!