Sara S. Andersen
Hutchinson, MN 55350 firstname.lastname@example.org
Self-motivated quality professional with over fourteen years experience
developing and implementing value added, compliant business processes.
. Demonstrates strong ability to build rapport and resolve complex
issues among multiple entities with conflicting interests.
. Educated and experienced in application of domestic and international
medical device regulations.
. Exemplary problem solving skills, able to identify problems and
influence the implementation of corrective processes.
. Dedicated and hardworking, with an unmatched drive to produce results.
. Compelling and authentic communicator with proven ability to apply
Master of Science, Regulatory Affairs for Drugs, Biologics and Medical
Northeastern University, Boston, MA
Bachelor of Science, Dairy Manufacturing - South Dakota State University,
Certificate, Configuration Management Principles and Implementation -
University of Houston, Houston, TX
. ASQ Certified Quality Technician
. ASQ Certified Biomedical Auditor
. ASQ Certified Quality Engineer
Hutchinson Technology Inc, BioMeasurement Division, Hutchinson, MN (5/1997
Quality Systems Engineer/Regulatory Affairs (10/2007 - Present)
. Provide leadership for the development and maintenance of the Quality
Management System ensuring compliance to domestic and international
. Serve as Management Representative, responsible for planning and
facilitating quarterly management review meetings.
. Identify Quality System deficiencies and ensures successful resolution
by leading and influencing business partners through collaboration.
. Manage Internal Audit program, responsible for process definition,
scheduling, assignment of auditors, and the timely closure of
. Serve as coordinator for CAPA and Post Market Feedback processes.
. Perform regulatory tasks including establishment listing, new market
clearance, technical documentation preparation, and correspondence
with regulatory authorities.
. Provide BioMeasurement Division consultation in the application of FDA
QSR and ISO 13485 to business practices.
Quality Engineering (7/2002 - 10/2007)
. Investigated, identified, and facilitated product and process
. Performed incoming and final inspection activities.
. Served as process owner for NCR, Calibration, and Preventive
. Responsible to ensure owned processes were compliant, efficient, and
. Selected to champion Quality Management System process automation,
transferred three Quality System processes from paper to electronic
. Maintained accurate and repeatable measurement equipment through the
application of statistical methods. Supported product verification and
validation tests by protocol definition and execution.
. Performed data trending and initiated appropriate action.
Analytical Instructor, Corporate Chemical Hygiene Officer - Corporate
Operations (5/1997 - 7/2002)
. Assessed needs and developed training materials provided to all
. Composed standard operating procedures to support laboratory
operations. Ensured good laboratory practices were understood and
. Responsible for laboratory compliance to safety and environmental
Bongards Creameries, Bongards, MN, Quality Coordinator (5/1994 - 5/1997)
. Developed and implemented raw ingredient inspection program.
Responsible for receiving, sampling, data flow, and approval of
. Performed facility audits and communicated results to management.
. Managed customer complaints leveraging customer experiences and
insight to drive product and service improvements.
. Reviewed and approved manufacturing records certifying compliance to
food safety regulations.
Available upon request