Quality Support Administrator

Infosoft Health; Cary (NC); Hybrid; USD 37,195 - 41,396; Full time

Job summary

Infosoft Health is seeking a Quality Support Administrator in Cary, NC. This role involves managing FDA-regulated customer safety advisory notices for patient safety recalls and ensuring compliance with industry regulations. Candidates must hold a Bachelor's degree and possess strong communication skills.

The ideal candidate will handle multiple projects, provide status updates, and maintain professional communication with diverse audiences.

Qualifications

• Bachelor’s degree or equivalent experience required.
• Strong communication skills needed, both verbal and written.
• Ability to handle semi-complex to complex projects and determine the critical path.

Responsibilities

• Organizes and tracks FDA-regulated customer Safety Advisory Notices for recalls.
• Manages multiple Update revisions/projects at once.
• Maintains professional communication with internal and external customers.

Skills

Communication Skills

Project Management

Data Management

Education

Bachelor’s degree or equivalent experience

Tools

SAP

Job description

Job Title: Quality Support Administrator

Pay Rate: $27 to $30.05/Hr

Duration: 12 months

Job Requisition: JP00077369

Location: Cary, NC (Hybrid)

Shift: 8 AM - 5 PM

This position is for the Healthcare Diagnostics division.

We are looking for a Quality Support Administrator.

Responsibilities

• Organizes, prepares, and tracks FDA-regulated customer Safety Advisory Notices for all patient safety recalls.
• Facilitating the timely completion of FDA-regulated updates
• Ensures proper customer signatures are obtained via electronic tracking and reporting.
• Simultaneously manages multiple Update revisions/projects at any given time.
• Works closely with Product Support Teams/Business Units and Data Management Teams to ensure install base accuracy and data integrity for FDA Compliance Reporting.
• Identifies and executes the project’s implementation strategy in accordance with Industry Regulations for timely communication of patient safety recalls.
• Proactively identifies areas of risk with non-compliance to industry regulations for patient safety recalls and non-mandatory updates.
• Provides status updates and escalations to various levels of management when compliance and on-time completion are at risk.
• Provides reports on progress and actions regularly by researching, documenting, and presenting findings.
• Maintains professional and courteous communication with internal and external customers to ensure smooth, clear, concise, and timely communication of all types.

Key Working Relationships

Contacts are with a diverse multi-national audience, including all 13 Invivo/Invitro Business Lines, Business Areas, External Customers, Regional Support Center, Customer Care Center, Education Services, CSML, Finance, Services Marketing, Customer Administration, Business Process Engineering (Quality), and Regulatory Affairs.

Requirements

• Bachelor’s degree or equivalent experience required
• Knowledge of SAP is a plus, but not required
• Ability to handle semi-complex to complex projectsand determine the critical path to improve timely performance.
• Strong communication skills needed, both verbal and written.
• Independently perform important areas of standard professional-level work that typically require processing and interpreting, more complex, less clearly defined issues.