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Amy Mathews, 117 River St, Boston, MA 02127
Phone (617) 247 8459 Cell (617) 847 1269
E-Mail: 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
Bayside Scientific International 1999 – 2002
Castle Island, Boston MA 02127
Position: Quality Engineer
1. Worked within a team developing medical devices with manufacturing systems, which will consistently produce high quality/performance, low cost products.
2. Responsible for implementing and updating 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. Drove 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. Responsible for the collection of operations data and the preparation of this data for monthly and quarterly management reviews.
7. Responsible for the collection and analysis of complaint product and data.
8. Responsible for the monitoring of test lots through the production area to the labs and the collection and presentation of data on a monthly basis.
Marriott Medical Ltd 1997 – 1999
South Boston, MA 02127
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, which made significant improvements to the manufacturing processes and the quality performance.
3. Verified scrap product and facilitated the continuous improvement programmes in place to improve the product yield.
4. Responsible for the collection of quality data and the presentation of this 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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