Karen Peifer
About Karen Peifer
Karen Peifer is the Principal Quality System Software Engineer at Silk Road Medical, Inc. in Plymouth, MN, with over 23 years of experience in enterprise business systems and regulated environments.
Current Role at Silk Road Medical
Karen Peifer is currently employed as a Principal Quality System Software Engineer at Silk Road Medical, Inc., located in Plymouth, MN. In this capacity, she is responsible for developing and managing the Quality System software program. She also takes an active role in training and coaching her cross-functional peers on the principles of quality system software and mentoring employees within the program.
Previous Experience at WuXi AppTec
Karen Peifer worked at WuXi AppTec as a Principal Computer System Validation Engineer from 2022 to 2023. Based in St. Paul, Minnesota, her responsibilities included ensuring the compliance and validation of computer systems. Her one-year tenure contributed to maintaining the high standards of quality and regulatory compliance WuXi AppTec is known for.
Career at Cardiovascular Systems, Inc.
From 2014 to 2022, Karen Peifer served as a Computer System Validation Specialist at Cardiovascular Systems, Inc. in New Brighton, MN. During her eight-year tenure, she specialized in building robust software validation programs to ensure the smooth execution of activities and the generation of audit-ready evidence. Her efforts were key in supporting the company's commitment to quality and compliance in a regulated environment.
Early Career at St. Jude Medical
Karen Peifer worked as a Software Quality Engineer at St. Jude Medical's Cardiovascular and Ablation Technologies Division from 2012 to 2014. Based in Plymouth, MN, she focused on ensuring the quality and compliance of software systems used in cardiovascular and ablation technologies. Her two-year tenure played a crucial role in maintaining the integrity and reliability of the software used in these critical medical devices.
Educational Background
Karen Peifer studied at Northern Illinois University, where she achieved a Bachelor of General Studies (BGS) in Art Therapy with a minor in Psychology. Her educational journey, spanning from 1982 to 1986, provided her with a diverse foundation that would later complement her extensive career in quality system software engineering and validation.