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QUALITY & REGULATORY

 

We are a fast-paced and innovative company, and our Quality & Regulatory teams mirrors this dynamic. Focused on collaboration and partnership, we all work together to support and promote quality and regulatory adherence across the company – something that is everyone’s responsibility. 

Our commitment to quality is at the heart of our brand and is vital to our growth and success. From design control to change control to document control, we are dedicated to quality every step of the way. We are responsible for ensuring that products are suitable for their intended purpose and produced right the first time and every time. That’s especially important in our business, because at Thermo Fisher Scientific, product quality can mean ensuring a proper cancer diagnosis, identifying dangerous substances, making an allergy discovery, facilitating a transplant procedure and countless other important outcomes. Our work also impacts our compliance with regulatory requirements around the world.
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A unique and exciting feature of the Regulatory function is that we are a team of professionals that work broadly across the organization and are truly integrated with all facets of the business. We’re involved in the full life cycle of products, and work closely with our quality, legal and manufacturing teams to establish the best methods to meet all regulations and standards. We are the face of the company to our regulators, and with our global scale and a wide range of products, you’ll get exposure to different regulations and government agencies across the countries, markets and regions where we work. 

QUALITY POLICY

We fulfill our Mission to enable our customers to make the world healthier, cleaner and safer by continuously improving the quality of our products and services and by ensuring global regulatory compliance.
Quality for our customers
Quality for our customers means they can rely on our products and services to consistently meet their specifications and requirements.
Quality for regulatory
Quality for regulatory authorities means that we operate at the highest ethical standards and meet or exceed all applicable regulatory requirements.
Quality for our colleagues
Quality for our colleagues means we take personal ownership to ensure our work meets customer requirements and is error-free from design through use.
Quality for our company
Quality for our company means we drive a continuous improvement culture that is enabled by Practical Process Improvement (PPI) and our company's Quality system.
We're serious about quality
“I am responsible for maintaining the efficiency of the Quality Management System at our Israel site according to the QMS standard. I make sure that only products that are in compliance with the requirements will be shipped to the customers. With my team of quality assurance specialists and quality control technicians, we support the process of the development new products that enable our customers to investigate diseases and develop new products to treat the patients.” Yossi
Yossi
"As a Regulatory Analyst, I'm responsible for the registration of our medical devices in South Korea and ensuring they comply with all government and regional regulation requirements. When a medical device enters the diagnostics market in South Korea, several authorities are involved to inspect its safety and efficacy. During this process, I need to be well-versed on the background and characteristics of the product. For example, the product’s label, manual and electronic components need to comply with the country’s specific requirements, and the clinical efficacy needs to be declared based on clinical trial data. Because the diagnostic and medical markets are directly related to public health and welfare, the safety and efficacy requirements are much stricter than those for products for the research field. Ensuring compliance with the respective standards and codes not only protects our company, it protects our customers and the end users who may benefit from the device.” Se-A (Nicole)

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