With a career built on precision, leadership and a commitment to excellence, Karen A. Liu has left a lasting imprint on the field of quality engineering. Her tenure as vice president of quality and regulatory at Carlsmed Inc. in San Diego County, California, marked the culmination of decades of impact in the medical device industry. At Carlsmed, she guided the company’s regulatory and quality assurance operations, ensuring that best practices were implemented across all levels. Her leadership contributed to significant advancements in compliance frameworks, risk management systems and product quality. Upon her retirement, she left the organization with a legacy of disciplined innovation and operational integrity.
Ms. Liu’s technical foundation began with a Bachelor of Science in materials engineering from Rensselaer Polytechnic Institute. Her academic training laid the groundwork for her problem-solving capabilities and engineering insight, which became central to her professional success. Over the years, she has added a range of professional certifications to her credentials, including regulatory affairs certification in devices from the Regulatory Affairs Professionals Society, European Union medical device regulation auditor from Exemplar Global Inc., lead auditor from the British Standards Institution, certified quality engineer and certified manager of quality and operational excellence from the American Society for Quality. Each certification reflects her ongoing commitment to mastery in her field.
Prior to her work at Carlsmed, Ms. Liu was a principal at Quality Solutions in San Diego, where she offered guidance to organizations seeking to strengthen their quality management systems. Drawing on her extensive industry knowledge, she helped clients align their operational practices with evolving regulatory standards. Her earlier work as a quality consultant under her own practice, Karen Liu, CQM/OE, expanded her reach to a diverse set of companies in the diagnostic and medical device sectors. She became known for her ability to identify and resolve complex quality issues with both strategic and technical precision.
Ms. Liu’s professional journey includes an impactful period as director of quality engineering at NuVasive, where she led major initiatives to improve manufacturing quality and regulatory compliance. She also brought her expertise to senior quality engineering roles at IntraLuminal Therapeutics and Medtronic Interventional Vascular, where she enhanced internal auditing systems and product development oversight. Earlier in her career, she held positions such as principal quality engineer at Alaris Medical Systems and senior quality engineer at Mallinckrodt. She also was a consultant for multiple medical device and diagnostics firms, helping to implement robust systems that would support long-term regulatory success.
Ms. Liu’s professional accomplishments are matched by her dedication to civic engagement and philanthropy. She is a board member of inewsource, an investigative nonprofit news organization based in San Diego. She supports a variety of animal welfare causes including the San Diego Zoo, Project Chimps in Georgia and the San Diego Humane Society. She also contributes to local nonprofit media outlets, demonstrating her belief in the power of journalism and advocacy to strengthen communities.
Originally from St. Louis, Ms. Liu has always approached life with a sense of curiosity and purpose. A seasoned global traveler, she has explored much of the world and now looks to the stars with an ambition to experience space travel. As she embraces retirement, her passion for discovery, service and continuous improvement remains as strong as ever. Her legacy in quality engineering continues to influence a new generation of professionals inspired by her example.