Senior Director of Quality Management Systems
4 weeks ago
The Senior Director of Quality Management Systems at Innovative Health LLC is responsible for establishing a Quality System that meets FDA and ISO requirements, customer expectations, and drives business growth. This leader champions continuous improvement efforts to establish an effective Quality System, providing quality leadership to all levels of the organization.
Key Responsibilities:
• Ensure all site departments remain compliant with FDA, ISO, Quality System, and regulatory requirements.
• Oversee CAPA processes, internal and supplier audits, customer complaints, documentation, and training.
• Initiate and implement quality improvement activities, such as Kaizen and Six Sigma, to enhance product lines.
• Educate and train employees on their impact in the quality management system.
• Serve as the primary quality control resource for problem identification, resolution, loss reporting, and continuous improvement.
• Lead internal audits and support external audits, including ISO certification.
• Perform root-cause analysis and problem-solving activities to identify effective corrective actions and process improvements.
• Establish collection and analysis systems for statistical data to predict trends affecting product quality.
• Manage document control, change control, and training activities, including maintenance of training records, training matrix, and competency matrix.
• Develop, implement, manage, and integrate a QMS for manufacturing plants.
• Manage Quality personnel daily.
• Design, implement, and document procedures for process control, process improvement, testing, and inspection.
• Establish and implement metrics for monitoring system effectiveness and enabling managers to make sound product quality decisions.
• Report to management on quality issues, trends, and losses.
Requirements:
Bachelor's degree in mechanical engineering, electrical engineering, manufacturing engineering, or business administration, or equivalent experience.
• Fifteen years of experience in Quality, including ten years of managing personnel.
• Experience working with FDA and audit preparedness.
• Regulatory Affairs background is preferred.
• Experience working in the medical device industry is a must.
• Experience with 21CFR820, Quality Systems Regulation, and ISO 13485 is a must.
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