Summary:

The Quality Assurance Coordinator is responsible for leading and partnering with cross functional groups to achieve the resolution of quality issues within the business. The Quality Assurance Coordinator will lead Receiving and Inspection activities associated with the Nonconformance Report process and the Materials Review Board.  They will champion activities within Materials Management, Documentation Management, and related metrics.

Essential Job Functions:

• Responsible for supporting and administering Nonconformance Reports by Ensuring that all reports are documented, investigated, and closed in a timely manner.
• Lead the Materials Review Board process for cross functional evaluation of nonconforming material.
• Oversee GMP inventory control system to ensure materials are traceable, accounted for and maintained in a controlled state.
• Ensure the RMA process for rejected materials flows efficiently to prevent material backlog.
• Interface directly with internal and external customers and regulatory agencies as required.
• Support Quality Metrics development and monitoring, participating in regular business and quality system performance reviews.
• Aid in root cause investigations & effectiveness checks for nonconforming incidents.
• Other duties as assigned.

Knowledge and Experience:

• 1+ years inventory management and/or quality experience
• Understanding of regulatory agency (cGMP/ISO) requirements.  
• Associate's degree, preferably in engineering, biological sciences, or a clinical health care specialty.
• Six Sigma and/or Lean Sigma experience a plus

Skills and Abilities:

Enthusiastic self-starter with excellent verbal, written, presentation, negotiation, and interpersonal communication skills.  Able to professionally represent the company to medical professionals, regulators, and custome