Quality Specialist II

About this role

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What you'll do

• As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
• Position Summary
• The CoE Post-Market Surveillance (PMS) Specialist supports global Business Unit (BU) PMS teams by maintaining and updating approved PMS documentation as part of ongoing lifecycle surveillance activities. This role operates within a centralized Center of Excellence model, leveraging standardized processes, templates, and best practices to ensure efficiency, consistency, and compliance.
• The Specialist updates previously approved PMS reports (e.g., PMSR, PSUR, PMPF, Literature Reviews) using analyzed data provided by BU PMS teams. The CoE does not perform final approval; BU PMS teams retain full legal responsibility for product oversight and report approval.
• This role ensures PMS reports are reviewed and updated at least annually and remain inspection-ready and compliant with applicable regulations (e.g., IVDR EU 2017/746).

Who can apply

• Bachelor’s degree in Life Sciences, Biomedical Sciences, Pharmacy, or related field

About Thermo Fisher

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