QA Manager-

3 weeks ago

Frederick, United States Latitude, Inc. Full time
Job DescriptionJob Description

QA Manager duties are to include managing the QMS to make changes towards cGMP compliance with applicable sections of 21 CFR Regulations for medical devices and QA monitoring of manufacturing, quality, logistics and customer management processes. This position requires writing, reviewing and updating SOP’s. This position will require internal and external auditing and laboratory support and the quality testing program.

Essential Job Functions:

  1. Make improvements in the Quality Management system to continuously move toward compliance with regulatory requirements for cGMP’s as defined in 21 CFR 820, GMP Regulations for medical Devices, applicable sections of 21 CFR 620, GMP Regulations for Biologicals and 21 CFR 1270 Tissue Regulations, as per our Quality Manual.
  2. Provide regulatory and quality system guidance to the organization.
  3. Maintain Quality Assurance system as currently defined in the company’s Quality Manual, which include records for manufacturing, shipping and receiving and matters related to customer satisfaction. These include batch records, personnel training records, equipment calibration and maintenance records.
  4. Develop and implement improved quality monitoring systems for manufacturing and shipping practices and write procedures (SOP’s) to accurately and clearly describe those.
  5. Monitor and document personnel training and assure that it is thorough and will result in quality manufacturing and testing practices by employees. Schedule and document training reviews to assure current best practices are being followed by employees.
  6. Manage and improve the existing label making and control process that assures label accuracy and can be smoothly coordinated with the manufacturing group.
  7. Manage and improve the customer complaint process. Monitor investigation of complaints and non-conformity issues as well as provide customers with quality related documentation (Certificates of Analysis, Certificates of Origin, etc.) as requested.
  8. Coordinate with the manufacturing and quality control departments to develop effective validation plans for new processes and the operation of new equipment and document the validation process.
  9. Manage the monitoring, measurement and review of internal processes, especially in the areas of product quality, complaint trends and alert management about systems that pose a risk or require modification to assure manufacture and delivery of high quality products and services.
  10. Host and be the point person for OEM Vendor audits of facilities.
  11. Monitor vendor quality and perform audits on suppliers, contractors and vendors.
  12. Review and release or quarantine/rejection of product after quality control testing has been completed.
  13. Perform other lab and office tasks as needed.

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