Lynn Carter serves as the Director of Quality Assurance at KARL STORZ Endovision, Inc., where she plays a pivotal role in ensuring the highest standards of quality and compliance within the medical device industry. With extensive experience in Quality Management Systems (QMS), Lynn is adept...
Lynn Carter serves as the Director of Quality Assurance at KARL STORZ Endovision, Inc., where she plays a pivotal role in ensuring the highest standards of quality and compliance within the medical device industry. With extensive experience in Quality Management Systems (QMS), Lynn is adept at navigating the complexities of regulatory frameworks, including U.S. Food and Drug Administration (FDA) regulations and international standards such as ISO 13485:2016, ISO 9001, and ISO 14001. Her recent leadership in the certification efforts for ISO 13485:2016 underscores her commitment to excellence and her ability to drive organizational change.
In her current role, Lynn oversees critical functions such as Document Control, Quality Engineering, and Quality Control, ensuring that all processes align with stringent regulatory requirements and industry best practices. Her expertise in Quality Assurance is complemented by her proficiency in Design Control, Validation, and Lean Manufacturing methodologies, which she employs to enhance operational efficiency and product quality. Lynn's cross-functional team leadership fosters collaboration across departments, enabling the successful implementation of Six Sigma principles to minimize variability and improve process outcomes.
Key projects under her direction have included the development of robust quality metrics and the integration of risk management strategies into product development cycles, which not only ensure compliance but also enhance product safety and efficacy. Lynn's unwavering dedication to quality and compliance positions her as a vital asset to KARL STORZ Endovision, Inc., as the company continues to innovate and lead in the medical device sector.
