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Amy Mathews, 117 River St, Boston, MA 02127
Phone 617 2478459 Cell phone 617 8471269
mathewsa@hotmale.com
A competent, dynamic, highly motivated and professional Quality Assurance specialist with 3 years excellent experience working to the highest FDA standards of compliance in the
medical device sector, possessing excellent communications and inter personal skills now seeking suitable position where I can apply these skills.
EXPERIENCE
Brighton Scientific Inc., Brighton, MA 1999 – 2002
Position: Quality Engineer
1. Coordinated the development of medical devices with manufacturing systems to consistently produce high quality/performance, low cost products.
2. Implemented and updated quality procedures, plans and design history files.
3. Ensured regulatory compliance to GMP’s of all medical device regulatory agencies (i.e. FDA, ISO and MDD).
4. Drive changes in procedures, standards, test equipment and gauges to facilitate continuous improvement and to maintain quality.
5. Worked cross functionally with Marketing, Regulatory, Product and Process Development, and Operations to ensure all issues are successfully resolved.
6. Collated operations data and the preparation of this data for monthly and quarterly management reviews.
7. Collated and analysed complaint product and data.
8. Monitored test lots through the production area to the labs and the collection and presentation of data on a monthly basis.
Dayton Medical Ltd., South Boston, MA 1997 – 1999
Position: Quality Technician
1. Assisted the Quality Engineer with the collection of yield and scrap data and the presentation of the data to the operations team on a daily basis.
2. Completed change requests on procedures making significant improvements to the manufacturing processes and the quality performance.
3. Liased with operators in the verification of scrap product and the continuous improvement programmes in place to improve the product yield.
4. Collated quality data presented this data at monthly reviews.
EDUCATION
South Shore High School, Boston MA 1989 – 1994
High School Diploma – Graduated with High Honours
Massachusetts Institute of Technology 1994 – 1997
BS in Quality Management
PERSONAL DETAILS
My hobbies include football, athletics, reading and art.
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