Quality Specialist II

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

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).

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)

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

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

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.