Supervisor, Quality

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

Position Summary
The CoE PMS Supervisor leads a centralized team responsible for maintaining and updating approved Post-Market Surveillance (PMS) reports for global Business Units (BUs). This role ensures efficient execution of PMS documentation updates using BU-provided analyzed data while maintaining compliance with regulatory requirements and internal standards.

The Supervisor oversees workload planning quality of deliverables and team performance ensuring that PMS reports are updated on schedule (at least annually) and are audit-ready. The role also ensures strong collaboration with BU PMS teams who retain full legal responsibility for product oversight and final approval of reports.

Key Responsibilities

• Lead and manage a team of PMS Specialists within the CoE
• Plan and prioritize workload to ensure timely delivery of PMS report updates
• Oversee updates to PMSR PSUR PMPF and Literature Review documents
• Ensure high-quality compliant and inspection-ready documentation
• Review draft reports prior to submission to BU PMS teams
• Ensure proper version control and documentation traceability
• Partner with BU PMS teams to align on timelines inputs and expectations
• Escalate risks delays or quality concerns appropriately
• Monitor KPIs (timeliness quality throughput) and drive performance improvements
• Support onboarding training and development of team members
• Drive standardization of templates tools and processes across PMS activities
• Support continuous improvement and efficiency initiatives

Scope of Role

In Scope:

• Oversight of PMS report updates and documentation lifecycle
• Team management and workload coordination
• Quality control and compliance of PMS documentation

Out of Scope:

• Final approval of PMS reports (owned by BU PMS teams)
• Quality event investigation or ownership
• Regulatory submissions (e.g. EUDAMED)

Qualifications

Education:

• Bachelors degree in Life Sciences Biomedical Sciences Pharmacy or related field

Experience:

• 5 years in medical devices IVD or regulatory/quality environment
• 2 years of leadership or supervisory experience preferred
• Experience with PMS reporting and regulatory documentation strongly preferred

Skills:

• Strong leadership and team management skills
• Advanced technical writing and document review capabilities
• Solid understanding of IVDR/MDR or similar regulations
• Strong organizational and project management skills
• Ability to manage multiple priorities and stakeholders
• Excellent communication and collaboration skills

Key Success Factors

• Consistent on-time delivery of high-quality PMS report updates
• Effective team leadership and resource management
• Strong partnership with BU PMS teams
• Maintenance of audit-ready and compliant documentation
• Continuous improvement of efficiency and standardization

Operating Model Context
This role operates within a centralized PMS Center of Excellence designed to improve efficiency scalability and consistency of PMS reporting. The CoE executes report updates while Business Units retain accountability for product oversight and final approval.