FAQs
What is the primary responsibility of a Product Assessor - Sterilisation?
The primary responsibility is to conduct sterilisation technical file reviews for medical devices against relevant European regulations within a defined timeframe.
What qualifications are required for this position?
Candidates should have a university or technical college degree in relevant studies such as microbiology, medicine, pharmacy, engineering, or other sciences, along with four years of industrial experience in medical device manufacturing.
What specific experience is required regarding sterilisation processes?
Candidates must have at least two years of experience operating relevant sterilisation processes such as ETO, Irradiation, Steam, and Aseptic processing.
Will there be opportunities for training and mentoring in this role?
Yes, the role includes providing guidance and assistance in training and qualifying junior staff members, as well as developing training materials to enhance the team’s skills.
What methods of sterilisation should the applicant be knowledgeable in?
Applicants should have knowledge of sterilisation processes in relation to medical device/procedure packs, including methods like MDS1005/MDS1011, MDN1211 for non-active, non-implantable devices, and MDT2008 for devices manufactured in clean rooms.
Is good communication important for this position?
Yes, effective communication with internal team members and clients is crucial for discussing product assessments and related activities.
How important is documentation and report writing in this role?
Very important, as good English literacy is required for the preparation and review of reports regarding product assessments.
What is the emphasis placed on risk management for medical device certifications?
The role requires working proactively to minimize risks associated with medical device certifications, highlighting the importance of risk management in the certification process.