Quality Assurance Specialist

Position Summary/ Objectives

The Quality Assurance Specialist will be responsible for managing several elements of the quality system to remain in alignment with the business needs. Primary focus will be on one or more of the Quality Management System core sub-systems (CAPA, Non-Conformances, Complaint Management, Supplier Management, Internal Audit, Deviations, etc.). This position ensures that the solid execution of company programs remain consistent with the overall company values. The ideal candidate has a solid understanding of the QA process and can support the strategic and operational objectives of the business. The successful candidate will possess a high degree of professionalism, maturity and confidentiality.

Essential Job Functions:

• Manage several core elements of the Quality Management System, including (but not limited to):
  • CAR/CAPA
  • Non-Conformance Management
  • Change Control
  • Complaint Management
  • Supplier Management
  • Internal Audit
  • Deviations
  • Training
• Provide support during External Audits (FDA, Notified Body, etc.)
• Maintain tracking/trending files for core QMS elements and run status reports as needed
• Perform periodic Internal Audits, as required.
• Foster a culture of collaboration, partnership, teamwork, customer service, and a drive for change and continuous improvement.
• Assume a lead role in identified elements of the QMS and take ownership and responsibility over those elements
• Propose and drive improvements to the Quality Management System to streamline business processes
• Assist with various special ad hoc projects and other duties as assigned