Product Assessor / Senior Product Assessor - Active Devices

As a Product Assessor at SGS, you play a crucial role in managing and conducting technical documentation reviews for Active Medical Devices. You'll ensure compliance with EU regulations and standards, guiding your team to deliver high-quality assessments while collaborating with various departments to enhance overall efficiency.

To qualify for the Senior Product Assessor position at SGS, candidates should have at least four years of professional experience in the healthcare field, including two years specifically related to the design or use of Active Medical Devices. Thorough knowledge of relevant standards and excellent written English skills are essential.

SGS supports its Product Assessors by offering access to a comprehensive benefits platform, flexible working arrangements, and continuous learning opportunities through SGS University. This dedication to growth ensures that team members are well-prepared to thrive in their roles and maintain high standards of service.

At SGS, a Senior Product Assessor can expect numerous career growth opportunities, including leadership roles within the team, specialized training in emerging technologies, and pathways to influence strategic decisions within the organization, fostering both personal and professional development.

The work environment for a Senior Product Assessor at SGS is collaborative and supportive, emphasizing teamwork. With a diverse international team, employees enjoy a culture that values open communication, continuous learning, and respect for each individual's contributions.

In answering this question, you should highlight specific experiences you have had reviewing technical files for Active Medical Devices. Detail the types of devices you worked with, the standards you applied, and the outcomes of your reviews to demonstrate your expertise.

A Senior Product Assessor should be well-versed in regulations such as the MDD and MDR, as well as related standards like EN 60601 and EN 62304. Discuss how your familiarity with these regulations has informed your assessments and decision-making processes in past roles.

To ensure quality and compliance, focus on establishing clear guidelines, regular training sessions, and consistent feedback mechanisms. Explain how you monitor KPIs and support your team in addressing any challenges they face in their reviews.

When managing a team, effective communication, active listening, and encouraging collaboration are key techniques. Discuss examples of how these practices have fostered a positive team dynamic and encouraged individual growth.

When addressing technical queries, it’s important to approach each question with thorough research and clear, concise communication. Share a specific example where you successfully resolved such queries, showcasing your understanding of Active Medical Devices and relevant standards.

For this question, recount a specific instance where you faced difficulties during an assessment. Highlight the challenges, your thought process in addressing them, and the eventual resolution to illustrate your problem-solving capabilities.

When mentoring junior assessors, I prioritize on-the-job training complemented by regular assessments of their understanding. Explain how you create an encouraging environment where questions are welcomed and learning is a shared journey.

Compliance is paramount in medical device assessments to ensure patient safety and regulatory requirements. Elaborate on how your past experiences have underscored the significance of compliance and its impact on the overall quality of medical device products.

Discuss the specific tools and methodologies you are familiar with, from project management software to assessment frameworks, that help streamline your review processes and ensure thoroughness in your evaluations.

Staying current with EU regulations is vital; therefore, I regularly review industry publications, participate in training, and attend workshops. Mention specific resources or networks that help you remain informed and how you integrate this knowledge into your work.