A growing manufacturing group in Nashville, TN is seeking for a Quality Assurance Analyst to join their team. The quality assurance analyst will support and maintain ISO guidelines and update compliance reporting. Additional responsibilities are below:
- Implementing and managing quality control systems, ensuring compliance with ISO 17025, ISO 9001, and IATF 16949 standards.
- Utilizing statistical process control to monitor product quality, recommending finished goods metrics.
- Providing technical support to various departments to ensure customer satisfaction targets are met and communicated effectively among stakeholders.
- Overseeing the hiring and training of Application and Process Support chemists for quality control and innovation labs.
- Establishing and maintaining Standard Operating Procedures within the laboratories.
- Managing day-to-day quality processes, ensuring documentation and activities align with QA and regulatory requirements.
- Overseeing Document Control, Incoming Inspection, Non-Conforming Materials, Training, and Internal Audit activities, ensuring all comply with quality standards.
- Leading supplier qualification programs and maintaining supplier rating records.
- Managing agency audits, including the preparations and response plans for any observations.
- Working alongside Regulatory Affairs to support agency regulatory requests, product registrations, and maintaining device listings.
Requirements:
- Candidates should possess a BS or BA
- 3-5 years of regulatory and ISO compliance experience
- Demonstrate knowledge with Quality Regulations and QMS System in a manufacturing environment, and display exposure to inspections by regulatory authorities.