Keisha Monique

Highly accomplished Life Sciences professional with over 10 years of robust experience in quality engineering, regulatory compliance, and complaint investigation within the medical device and pharmaceutical industries. Adept at leveraging Six Sigma methodologies and extensive knowledge of FDA regulations (21 CFR Parts 4, 11, 50, 58, 210, 211, 600, 610, 803, 809, 820, 821, 830) and ISO standards (9001, 13485, 14971) to enhance product quality, ensure patient safety, and drive significant process improvements. Proven expertise in meticulously investigating complex complaints, performing root cause analysis, managing regulatory reporting decisions for Class I, II, and III medical devices, and collaborating with cross-functional teams to achieve compliance and deliver effective solutions. Demonstrated ability to lead remediation efforts, support audits and inspections, and provide comprehensive training, consistently maintaining a primary commitment to patient safety and product quality.