Sara S. Andersen

***** ***** ** ****: 320-***-****

Hutchinson, MN 55350 abl9kj@r.postjobfree.com

Home: 320-***-****

SUMMARY

Self-motivated quality professional with over fourteen years experience

developing and implementing value added, compliant business processes.

QUALIFICATIONS

. 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

statistical techniques.

EDUCATION

Master of Science, Regulatory Affairs for Drugs, Biologics and Medical

Devices Current

Northeastern University, Boston, MA

Bachelor of Science, Dairy Manufacturing - South Dakota State University,

Brookings, SD

Certificate, Configuration Management Principles and Implementation -

University of Houston, Houston, TX

. ASQ Certified Quality Technician

. ASQ Certified Biomedical Auditor

. ASQ Certified Quality Engineer

PROFESSIONAL EXPERIENCE

Hutchinson Technology Inc, BioMeasurement Division, Hutchinson, MN (5/1997

- Present)

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

regulations.

. 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

findings.

. 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

improvements.

. Performed incoming and final inspection activities.

. Served as process owner for NCR, Calibration, and Preventive

Maintenance processes.

. Responsible to ensure owned processes were compliant, efficient, and

effective.

. Selected to champion Quality Management System process automation,

transferred three Quality System processes from paper to electronic

format.

. 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

corporate laboratories.

. Composed standard operating procedures to support laboratory

operations. Ensured good laboratory practices were understood and

followed.

. Responsible for laboratory compliance to safety and environmental

regulations.

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

incoming product.

. 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.

REFERENCES

Available upon request

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