Quality Assurance Analyst

1 week ago

Norcross, Georgia, United States Sebia USA Full time

QUALITY ASSURANCE ANALYST

Responsible for overseeing Quality Assurance functions to guarantee adherence to regulatory standards, ISO guidelines, and internal protocols. Executes all Document Control responsibilities to ensure compliance with the organizational quality framework and aids in the management of the electronic Quality Management System (QMS).

  • Conducts final evaluations and approves new documents and revisions before dissemination.
  • Administers and monitors communications and notifications to clients regarding product details, recalls, and investigation of complaints.
  • Handles and tracks escalated complaints directed to the manufacturing facility, including the distribution of root cause analyses and recommendations to internal teams and clients as necessary.
  • Supervises the CAP Proficiency Testing initiative, which includes conducting testing surveys on internal instruments and presenting findings to relevant teams.
  • Performs final assessments of documents generated during instrument reception testing and, where applicable, holds final authority for incoming materials, including packaging and labeling used in production.
  • Manages the Approved Vendor List, including additions and removals in line with regulatory standards and internal policies.
  • Oversees the change order (CO) procedure and ensures all modifications are accurately 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 processes, assisting other departments in formatting quality system documents. Provides word processing support as needed to prepare all such documentation.
  • Administers the electronic QMS and 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 discrepancies are identified, investigated, and entered into the CAPA system when necessary.
  • Maintains the Training Program and promotes company-wide awareness of the Quality System, providing support and training on Quality matters.
  • Supports organizational infrastructure, including facilities and equipment, ensuring validation, calibration, and maintenance of these areas as mandated by regulations and internal systems (as applicable).
  • Supervises the complaint management process to ensure compliance with regulatory and internal standards.
  • Performs additional responsibilities as assigned by the Director of Regulatory & Quality Affairs.

KNOWLEDGE: This role necessitates a strong understanding of FDA and international regulations, directives, and standards applicable to medical devices.

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

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