Quality Assurance Coordinator

Job description

Our client is seeking an experienced and highly skilled Quality Assurance Coordinator. This opportunity provides a work-life balance Monday-Friday schedule along with being part of a unique, culture-based company.

Skills:

• In-depth understanding of ISO 13485:2016 and FDA 21CFR820
• Experience working in facilities that are compliant with to aforementioned standards/requirements
• Proficient in Root Cause Analysis
• Knowledgeable with CAPA's
• Proficient in Microsoft Office
• Sharp attention to detail
• Great team player - established communication skills to ensure all stakeholders are aware
• Self-driven and able to work with minimal supervision
• Able to sit, stand and walk around for long hours at a time
• Experience and certification for Internal Audits (previous certification does not have to be current)

Responsibilities/Tasks:

• Create reports documenting errors and issues for fixing
• Help to review and develop quality assurance standards and company processes/records
• Manage equipment calibration for manufacturing plant
• Lead and participate in internal quality audits on a quarterly basis
• Identify processes, situations, etc., where the organization is meeting requirements, as well as identify opportunities for improvement.
• Develop audit plans and schedules
• Evaluate production processes for compliance with quality requirements
• Assist with 3rd party audits