Jobs at Zila, Inc.

The Quality Assurance Specialist is responsible for maintaining and improving the Quality Management System (QMS) by managing customer complaints, CAPA, nonconformance investigations, post-market surveillance, internal audits, calibration, environmental monitoring, and quality documentation. The role works closely with Quality, Engineering, and Production teams to ensure compliance with ISO 13485 and regulatory requirements while driving continuous quality and process improvements in a medical device manufacturing environment. 

Essential Duties and Responsibilities:

• Assist Quality Management in establishing, implementing and maintaining the quality management system.
• Review daily feedback, including customer complaints, non-conforming reports, Supplier quality issues, etc., and assess the need for Corrective Actions, including CAPA, reporting to Regulatory Authorities, post market surveillance and risk mitigation update.
• Review, update and monitor quality systems documentation (i.e. quality plans, post market surveillance, etc.) and maintain corresponding logs.
• Summarize monthly customer feedback, quality related activities, coordinate with engineering and report findings to Quality Manager.
• Conduct internal quality audits.
• Coordinate calibration and environmental monitoring activities, summarize and report findings to Quality Manager.
• Verify quality documentation to ensure accuracy. 
• Assist in the collaboration of production and quality control to resolve in-house quality concerns.
• Maintain work area in a clean and orderly fashion.
• Adhere to company and departmental policies and practices as well as ISO, safety, and security measures.

Additional Duties and Responsibilities:

• Continually look for ways to improve processes, procedures and/or products; evaluating and participating in improvements as appropriate.
• Occasional travel to attend training / meetings or conduct Internal /Supplier Audits, as needed.
• Generate reports and reconcile information.
• Provide accurate and complete information in a prompt manner.
• Other projects or tasks as assigned.

• Bachelor’s degree from a four-year college or university in a scientific field and 2 to 4 years related experience. Previous medical device quality experience is desirable.