Location: Ronkonkoma, NY
Schedule: Mon-Fri 8:30am-5pm

Position would be Temp to Perm.

Responsibilities:
· As a Quality Coordinator, you are required to assist with all quality activities and projects as directed by the Quality Assurance Manager
· Perform the role of an analyzer and investigator to help improve products, processes, vital information, and data.
· Address customer’s requests for information cases pertaining to our product specifications and quality management system.
· Ensure that products meet the established standards of both quality and regulatory requirements including reliability, usability, performance, and safety.
· Work with teams and committees to ensure our products meet our organization’s standards across the board.
· Support all efforts to ensure that our system of record (ERP system) is maintained with accurate, precise, and current information.
· Collect, organize, and maintain material and product documentation to support regulatory needs.
· Review customer specifications for accuracy
· Assist where needed in the coordination and release of product Change Notifications.
· Communicate with management to address and attain solutions to issues.
· Recommend, implement, and direct others to modify and improve operational methods and practices along with overall strategy to enhance process effectiveness.
· Investigate customer complaints and non-conformance issues and respond as needed to requests for information from external and internal customers.
· Participate in corrective/preventives and their root cause analysis.
· Perform internal audits of all management systems as per the audit schedule.
· Support on-site audits conducted by external parties (customers, regulatory bodies)
· Work on additional tasks and projects as directed by the Quality Assuraure Manager

Requirements
· Strong understanding of FDA regulations

· Hands-on experience maintaining and improving QMS processes, including CAPA, document control, non-conformance reporting, internal audits, and supplier quality management

· Ability to analyze data, identify trends, and drive root cause investigations with strong documentation and reporting skills.

· Excellent verbal and written communication abilities; able to work effectively with cross-functional teams, including R&D, manufacturing, regulatory, and customer service.