Quality Specialist II

Job Description :

Work Schedule

Environmental Conditions

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).

Key Responsibilities

• Update approved PMS reports (PMSR, PSUR, PMPF, Literature Reviews) using BU-provided data
• Ensure timely annual or periodic updates of PMS documentation
• Maintain version control and document traceability
• Compile and integrate BU data into standardized templates
• Ensure clarity, accuracy, and audit readiness of documentation
• Identify inconsistencies or potential safety signals and escalate to BU teams
• Collaborate with BU PMS teams to gather inputs and incorporate feedback
• Deliver draft reports to BU teams for review and approval
• Apply standardized templates and support process improvements

Scope of Role

In Scope:

• Updating and maintaining PMS reports
• PMS document lifecycle management
• Supporting centralized PMS processes

Out of Scope:

• Approval of PMS reports (BU responsibility)
• Quality event tracking/investigation
• Regulatory submissions (e.g., EUDAMED)

Qualifications

Education:

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

Experience:

• 1-3 years in medical devices, IVD, or regulatory/quality environment

Skills:

• Strong technical writing skills
• Data interpretation and analytical ability
• High attention to detail
• Familiarity with IVDR/MDR preferred
• Proficiency in Microsoft Office

Key Success Factors

• Timely delivery of compliant PMS reports
• Strong collaboration with BU teams
• Consistent use of templates and processes
• Maintenance of audit-ready documentation

Operating Model Context
This role is part of a centralized PMS Center of Excellence designed to improve efficiency, standardization, and scalability while maintaining compliance and supporting Business Unit ownership of product responsibility.