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Quality Assurance Specialist

2 months ago

Norcross, Georgia, United States Sebia USA Full time
Job Summary

Sebia USA is seeking a highly skilled Quality Assurance Specialist to oversee Quality Assurance activities and ensure compliance with regulatory agencies, ISO, and company requirements. The ideal candidate will have a strong background in quality assurance and regulatory affairs, with excellent knowledge of FDA and international regulations.

Key Responsibilities
  • Quality Assurance Activities: Oversee Quality Assurance activities to ensure compliance with regulatory agencies, ISO, and company requirements.
  • Document Control: Perform all Document Control functions to assure compliance with the company quality system and contribute to the management of the electronic QMS system.
  • Complaint Handling: Manage and track complaints submitted to manufacturing site, including dissemination of root cause and recommendations to internal teams and customers, as needed.
  • CAP Proficiency Testing: Oversee CAP Proficiency Testing program, including testing surveys on in-house instruments and presenting testing data to internal teams.
  • Approved Vendor List: Oversee the Approved Vendor List, additions, and removals in accordance with regulatory requirements and internal procedures.
  • Change Order Process: Oversee the change order (CO) process and verify that all changes are properly implemented. Responsible for tracking documents through the system.
  • Electronic QMS: Manage electronic QMS and systems (Acts as system coordinator and SME).
  • Internal Audit Program: Conduct and assist as needed with the Internal Audit Program.
  • Nonconformance Reports: Coordinate the Nonconformance Reports and Corrective and Preventive Action (CAPA) process to ensure compliance to regulatory and internal requirements.
  • Training Program: Maintain the Training Program and assist with company awareness of the Quality System.
  • Facilities and Equipment: Support company infrastructure including facilities and equipment. Ensure validation, calibration, and maintenance of these areas as required by regulations and internal systems.
Requirements
  • Education: Bachelor's Degree.
  • Experience: Minimum of five (5) years' experience in Quality Assurance or Regulatory Affairs in an FDA regulated industry.
  • Knowledge: Excellent knowledge of FDA and international regulations, directives, and standards governing medical devices.