Edith Bell Email & Phone Number

Buford, Ga, Us

Buford, Georgia, Us

•Evaluates procedures for compliance with applicable regulations/guidelines and provides recommendations to management for continuous process improvements. •Hosts regulatory inspections. •Provides training for Quality Assurance personnel. •Serves as author of Quality Assurance SOPs.•Oversees documentation, reporting and closure of compliance issues •Manages and maintains data bases for the quality system and prepares annual reports and quality trending reports.•Acts as the appointed Management Representative with the authority and responsibility for ensuring that the quality system requirements are effectively established and maintained in accordance with ISO 13485 and FDA QSR 820 requirements.•Schedules and leads Management Reviews •Ensures that all Device History Records are reviewed in a timely manner and assesses the quality impact of any process deviations prior to release of product. •Manages all aspects of the internal nonconformance management systems; specifically, CAPA, deviations, supplier incident reports and close out of customer complaints. •Responsible for maintenance and tracking of Returned Materials Authorization (RMA) information. •Performs data collection for annual reporting and other trends, as required. Maintains the trending databases for repairs and complaints.•Monitors day-to-day production quality.•Maintains FDA compliance with all products; Represents company in FDA Audits•Main point of contact and project manager of GSA (U.S. General Service Administration)/FSS (Federal Supply Schedule) working with appointed Management Agency for various GSA/FSS submission

• Set educational standards and goals resulting in a increase of enrollments.• Set budgeting standards for the allocation of funds for staff, materials and equipment resulting in more efficient cash flow efficiencies.• Interfaced with the Board of Directors to advise and consult on all school activities. • Prepared and maintained attendance, activity, planning and personnel reports and records. • Planned and coordinated school logistics programs.

Teaching Mandarin Chinese language and culture at a grant funded summer camp.

Medical Device Global Registration Research for Regulatory.

Norcross, Ga, Us

Support Chinese translated projects in Department of Regulatory Affairs. To include verify accuracy of translated medical device product inserts, package labels which include all related documents.