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- Tasks: Oversee Sterilization product assessments and ensure compliance with regulatory standards.
- Company: Join SGS, the global leader in testing, inspection, and certification.
- Benefits: Enjoy hybrid working, competitive salary, and opportunities for professional growth.
- Why this job: Be part of a collaborative culture that values diversity and teamwork.
- Qualifications: Degree in relevant sciences with four years of experience in medical device manufacturing.
- Other info: Experience in sterilization processes is highly advantageous.
The predicted salary is between 36000 - 60000 £ per year.
We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,500 employees operate a network of 2,500 offices and laboratories, working together to enable a better, safer and more interconnected world.
As a Product Assessor, you will play a crucial role in our organization by overseeing Sterilization product assessments and conducting technical file reviews in strict adherence to regulatory requirements, including the European Medical Device Directive and Medical Device Regulation for Class IIa/IIb and/or Class III. Your primary focus will be to ensure the technical soundness of reviews and compliance with all relevant standards.
Responsibilities:- Conduct comprehensive Sterilization product assessments in line with regulatory requirements for medical devices.
- Support CE marking activities conducted by SGS, contributing to the overall certification process.
- Effectively communicate with colleagues and clients regarding product assessments and related activities.
- Work proactively to minimize risks associated with medical device certifications.
- A degree or equivalent qualification with Microbiology modules or relevant studies (e.g., medicine, pharmacy, engineering, or other related sciences).
- Four years industrial experience with medical device manufacturing that includes at least two years of experience in the operation of the relevant sterilization processes, particularly in following methods (MDS1005/ MDS1011).
- In-depth knowledge of sterilization processes including ETO, Irradiation, Steam/Moist heat, Aseptic, Hydrogen Peroxide and other sterilization methods.
- In-depth knowledge of clean room/environmental controls and validation processes.
- In depth knowledge of shelf-life studies and validation for sterile devices.
- Familiarity with non-active, non-implantable devices for disinfection, cleaning, and rinsing, as well as solutions for disinfecting medical devices. (MDN1211)
- Previous experience conducting Sterilization Product Assessments for a Certification/Notified body is highly advantageous.
- Professional English.
- We provide hybrid working environment.
- Opportunity to work with a global leader in inspection, verification, testing, and certification.
- Collaborative and inclusive work environment.
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
Join Us: At SGS, we are dedicated to fostering an open, friendly, and supportive culture that thrives on teamwork. We value diversity and provide endless opportunities to learn, grow your expertise, and fulfil your potential.
Product Assessor / Senior Product Assessor - Sterilization employer: SGS
Contact Detail:
SGS Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Product Assessor / Senior Product Assessor - Sterilization
✨Tip Number 1
Familiarise yourself with the European Medical Device Directive and Medical Device Regulation. Understanding these regulations will not only help you in interviews but also demonstrate your commitment to compliance, which is crucial for the role.
✨Tip Number 2
Network with professionals in the sterilization and medical device sectors. Attend industry conferences or webinars to connect with potential colleagues at SGS and gain insights into current trends and challenges in the field.
✨Tip Number 3
Prepare to discuss specific sterilization processes you have experience with, such as ETO or steam heat. Being able to articulate your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Showcase your problem-solving skills by preparing examples of how you've minimised risks in past projects. This will highlight your proactive approach and ability to contribute positively to SGS's certification process.
We think you need these skills to ace Product Assessor / Senior Product Assessor - Sterilization
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in sterilization processes and medical device manufacturing. Emphasise any specific qualifications or projects that align with the job description.
Craft a Strong Cover Letter: Write a cover letter that clearly outlines your passion for the role and how your background in microbiology or related fields makes you a suitable candidate. Mention your experience with CE marking and regulatory compliance.
Highlight Relevant Experience: In your application, focus on your four years of industrial experience, particularly the two years spent in sterilization processes. Provide examples of how you've contributed to product assessments and risk minimisation.
Showcase Communication Skills: Since effective communication is key in this role, include examples of how you've successfully communicated with colleagues and clients in previous positions. This will demonstrate your ability to work collaboratively.
How to prepare for a job interview at SGS
✨Know Your Regulations
Familiarise yourself with the European Medical Device Directive and Medical Device Regulation. Being able to discuss these regulations confidently will show your understanding of the compliance landscape in which SGS operates.
✨Highlight Relevant Experience
Prepare to discuss your industrial experience, particularly your work with sterilization processes. Be specific about the methods you've used and how they relate to the role, as this will demonstrate your practical knowledge.
✨Showcase Communication Skills
Since effective communication is key in this role, think of examples where you've successfully communicated complex information to colleagues or clients. This will illustrate your ability to convey technical details clearly.
✨Emphasise Teamwork and Collaboration
SGS values a collaborative environment, so be ready to share experiences where you worked as part of a team. Highlight how you contributed to group success and how you can bring that spirit to their organisation.
