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Quality Assurance Analyst

2 months ago

Norcross, Georgia, United States Sebia USA Full time

QUALITY ASSURANCE ANALYST

The Quality Assurance Analyst is responsible for supervising Quality Assurance functions to guarantee adherence to regulatory standards, ISO guidelines, and internal company protocols. This role encompasses all Document Control responsibilities to ensure compliance with the organization's quality management system and aids in the administration of the electronic Quality Management System (QMS).

  • Conducts final evaluations and authorizations for new documents and revisions before they are disseminated.
  • Oversees and monitors communications and notifications to clients regarding product details, recalls, and investigation of complaints.
  • Manages and tracks escalated complaints directed to the manufacturing site, including the distribution of root cause analyses and recommendations to internal teams and clients as necessary.
  • Supervises the CAP Proficiency Testing program, which includes conducting testing surveys on in-house instruments and presenting the findings to internal teams.
  • Performs final assessments of documents generated during instrument reception testing and, where applicable, holds final authority for the acceptance of incoming materials, including packaging and labeling used in production.
  • Manages the Approved Vendor List, including additions and removals in line with regulatory mandates and internal procedures.
  • Oversees the change order (CO) process, ensuring that all modifications are correctly executed. Responsible for tracking documents throughout the system and maintaining a comprehensive list of all controlled documents.
  • Contributes to the development of document approval and change control procedures while assisting other departmental personnel in formatting all quality system documents. Provides word processing support as needed to prepare such documentation.
  • Administers the electronic QMS and related systems, acting as the system coordinator and subject matter expert (SME).
  • Conducts and assists with the Internal Audit Program as required.
  • Coordinates the Nonconformance Reports and Corrective and Preventive Action (CAPA) processes to ensure compliance with regulatory and internal standards, ensuring timely completion of actions. Manages the nonconformance handling system to guarantee all nonconformities are identified, investigated, and documented in the CAPA system when necessary.
  • Maintains the Training Program and promotes company-wide awareness of the Quality System, providing support and training on Quality-related issues.
  • Supports the company’s infrastructure, including facilities and equipment, ensuring validation, calibration, and maintenance of these areas as required by regulations and internal systems.
  • Supervises the complaint management process to ensure adherence to regulatory and internal standards.
  • Performs additional responsibilities as assigned by the Director of Regulatory & Quality Affairs.

KNOWLEDGE: This position necessitates a comprehensive understanding of FDA and international regulations, directives, and standards that govern medical devices.

EXPERIENCE: A minimum of five (5) years of experience in Quality Assurance or Regulatory Affairs within an FDA-regulated industry is required, along with a Bachelor's Degree.