Position Overview
The Quality Support Administrator plays a critical role in supporting FDA-regulated patient safety activities within the Healthcare Diagnostics division. This position is responsible for coordinating, tracking, and ensuring timely completion of customer Safety Advisory Notices and regulatory updates while maintaining strict compliance with industry regulations.
The role requires strong organizational skills, attention to detail, and the ability to manage multiple concurrent projects in a fast-paced, compliance-driven environment.
Key Responsibilities
- Coordinate, prepare, and track FDA-regulated Customer Safety Advisory Notices related to patient safety recalls.
- Facilitate timely execution and completion of regulatory updates.
- Ensure accurate and complete customer documentation, including obtaining required electronic signatures through tracking and reporting systems.
- Manage multiple update revisions and projects simultaneously while maintaining compliance deadlines.
- Collaborate closely with Product Support Teams, Business Units, and Data Management Teams to ensure install base accuracy and data integrity for FDA compliance reporting.
- Develop and execute implementation strategies aligned with industry regulations to support timely communication of patient safety recalls.
- Proactively identify potential compliance risks related to mandatory and non-mandatory updates.
- Provide regular status updates and escalate risks to management when compliance timelines are at risk.
- Research, document, and present findings through detailed progress and compliance reports.
- Maintain professional, clear, and timely communication with internal and external stakeholders.
Key Working Relationships
This role interfaces with a diverse, multinational audience across:
- All 13 Invivo/Invitro Business Lines and Business Areas
- Regional Support Centers
- Customer Care Centers
- Education Services
- CSML
- Finance
- Services Marketing
- Customer Administration
- Business Process Engineering (Quality)
- Regulatory Affairs
- External Customers
Qualifications & Requirements
- Bachelor’s degree required (or equivalent professional experience).
- Knowledge of SAP preferred but not required.
- Ability to manage semi-complex to complex projects and determine critical paths to ensure on-time performance.
- Strong written and verbal communication skills.
- Ability to independently perform professional-level work involving analysis, interpretation, and resolution of complex or less-defined issues.