Quality Assurance Specialist

QUALITY ASSURANCE SPECIALIST

Oversees Quality Assurance activities to ensure compliance with regulatory agencies, ISO and company requirements. Performs all Document Control functions to assure compliance with the company quality system and contributes to the management of the electronic QMS system.

• Final review and sign off approval for new documents/new document revisions prior to distribution.
• Manages and tracks notifications and letters to customers related to product information, recalls, and complaint investigations.
• Manages and tracks complaint escalations submitted to manufacturing site, including dissemination of root cause and recommendations to internal teams and customers, as needed.
• Oversee CAP Proficiency Testing program, including testing surveys on in-house instruments and presenting testing data to internal teams.
• Final review of documents produced during instrument reception testing and where applicable final disposition authority for incoming materials, including packaging and labeling, used in product manufacturing.
• Oversees the Approved Vendor List, additions, and removals in accordance with regulatory requirements and internal procedures.
• Oversees the change order (CO) process and verifies that all changes are properly implemented. Responsible for tracking documents through the system. Maintains a master list of all controlled documents.
• Contributes to establishing document approval and change control procedures in addition to assisting other department personnel in formatting all quality system documents. Provide word processing services as required to prepare all such documentation.
• Manages electronic QMS and systems (Acts as system coordinator and SME)
• Conduct and assist as needed with the Internal Audit Program.
• Coordinates the Nonconformance Reports and Corrective and Preventive Action (CAPA) process to ensure compliance to regulatory and internal requirements and to ensure actions are completed in a timely manner. Manages the nonconformance handling system to ensure all nonconformities are identified, investigated, and entered in the CAPA system, if necessary
• Maintains the Training Program and assists with company awareness of the Quality System and provides support and training on Quality issues.
• Supports company infrastructure including facilities and equipment. Ensures validation, calibration and maintenance of these areas as required by regulations and internal systems (as applicable by site)
• Oversees the complaint process to ensure regulatory and internal requirements are met.
• Other duties as assigned by Director of Regulatory & Quality Affairs.

KNOWLEDGE: The position requires excellent knowledge of FDA and international regulations, directives and standards governing medical devices.

EXPERIENCE: This position requires a minimum of five (5) years’ experience in Quality Assurance or Regulatory Affairs in an FDA regulated industry plus a Bachelor's Degree.

This is role is based in Norcross, GA - no relocation provided.