SGS Microbiology Job Opening – Product Assessor Vacancy Available

Job Description

As a Product Assessor you’ll be responsible for conducting Sterilisation product assessments and technical file reviews in compliance with all applicable requirements including the European Medical Device Directive and Medical Device Regulation for Class IIa /IIb and/or Class III. You’ll ensure that reviews are technically sound and in compliance with all applicable requirements.

You’ll also support CE marking activities carried out by SGS, support in training and qualification of more junior staff, and create training materials.

You’ll communicate with team members and

client with regards to the product assessment or other activities performed and work to minimise risks associated with medical device certification.

Qualifications

The successful candidate will bring extensive experience within medical device manufacturing. You’ll have experience and knowledge in the operation of the relevant sterilization processes (ETO, Irradiation, Steam, Aseptic etc.), clean room controls, including validation of the considered process for which they wish to be qualified.

Experience of conducting sterilisation Product Assessments for another Certification/Notified body (Sterilisation-Technical File reviewer) would be advantageous.

In addition the ideal candidate will also bring;

• A degree or equivalent qualification which includes Microbiology modules or relevant studies e.g. medicine, pharmacy, engineering or other relevant sciences
• Good communication techniques through electronic mediums
• Good written English skills (as reports will be reviewed/queried in English)
• Medical device/ procedure packs Sterilisation process knowledge is required in following methods-
  • (MDS1005/ MDS1011)
  • ETO Sterilization
    • Irradiation Sterilization
    •  Steam (and dry) Sterilization
    • Aseptic Sterilization
  • any additional knowledge will be advantageous i.e.
    • Hydrogen Peroxide (gas plasma)
    • Any other sterilization methods for Medical devices
•  Non-active, non-implantable devices for disinfection, cleaning and rinsing (MDN1211)
• Solutions for disinfecting medical devices, contact lens care, catheter lock solutions
• Devices manufactured in clean rooms and associated controlled environments (MDT2008)

APPLY ONLINE

Possible Interview Questions:

1. Can you explain your experience and knowledge in conducting sterilization product assessments? How familiar are you with the relevant sterilization processes such as ETO, Irradiation, Steam, and Aseptic Sterilization? Answer: I have extensive experience in conducting sterilization product assessments, specifically for medical devices. I am well-versed in the operation of sterilization processes like ETO, Irradiation, Steam, and Aseptic Sterilization. I have successfully validated these processes and ensured compliance with applicable regulations and standards.
2. Have you previously worked as a Sterilization-Technical File reviewer for a Certification/Notified body? Can you describe your experience in this role? Answer: Yes, I have worked as a Sterilization-Technical File reviewer for a Certification/Notified body. In this role, I conducted thorough reviews of technical files related to sterilization processes. I ensured that the files complied with relevant regulations and guidelines, assessed the efficacy of sterilization methods used, and provided recommendations for improvement when necessary.
3. How do you ensure that product assessments and technical file reviews are conducted in compliance with applicable requirements, such as the European Medical Device Directive and Medical Device Regulation? Answer: I ensure compliance by thoroughly understanding the requirements stated in the relevant directives and regulations. I conduct comprehensive assessments and reviews, ensuring technical soundness and adherence to all applicable requirements. I stay updated with the latest regulatory changes and guidelines to ensure ongoing compliance in my assessments and reviews.
4. Can you discuss your experience in supporting CE marking activities? How have you contributed to the certification process for medical devices? Answer: I have actively supported CE marking activities by providing technical expertise and guidance. I have assisted in compiling the necessary documentation, conducting risk assessments, and ensuring that the devices meet the essential requirements for certification. I have collaborated closely with internal teams and clients to streamline the certification process and minimize risks associated with medical device certification.
5. How do you effectively communicate with team members and clients during the product assessment process? Can you provide an example of a challenging communication scenario and how you resolved it? Answer: Communication is key in the product assessment process. I ensure clear and concise communication with team members and clients through various electronic mediums. In a challenging scenario, I encountered a discrepancy in the technical documentation provided by the client. I promptly reached out to clarify the issue, engaged in open and transparent communication, and worked collaboratively to resolve the discrepancy. This proactive approach helped maintain effective communication and ensured the accuracy and completeness of the assessment process.

Note: The answers provided are sample responses and can be tailored based on the individual’s specific experiences and qualifications.

Editor’s Note: SGS Microbiology Job Opening – Product Assessor Vacancy Available. Please ensure you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of the latest industry news. Follow us on social media like Twitter, Telegram, Facebook and Instagram.