1. Assunta Nimley-Phillips (203) 430-1724
64 Kilborn Street, West Haven, CT 06516 · phillips.assunta@yahoo.com
http://www.linkedin.com/pub/assunta-nimley-phillips/a7/4b3/205/en
Profile
Medical Devices Q/A inspection with 24 years of experience. I have extensive training in
this area, and am opened to learn any new aspect of the work that will bring about
improvement. I can multitask, and am well organized. I have good communications skills,
and meet targets for reporting. I have computer skills – Word, Excel, and PowerPoint.
Very opened to add more knowledge.
CORE SKILLS
 SPC (Statistical Process Control)
 SOP (Standard Operating Procedures)
 Micrometers, Calipers knowledge
 Product Capability (CPK- Product capability)
 Audits
 Process Improvement
 Conformance & Non-conformance reporting
 Quality Management Systems (QMS)
Professional Experience:
Cooper Surgical (Contract), Trumbull, CT. 2015 – 2015
Product Surveillance Associate
 Contacted Local, National and International end-users of medical devices via phone and email
to gain feedback on product use and safety.
 Evaluated, investigated, tracked and completed complaints from patient safety perspective,
 Identified complaints requiring further evaluation and documented on MDR Determination
forms.
 Prepared and filed initial MDRs and supplemental reports per FDA requirement.
Medtronic/Covidien/Tyco Healthcare, North Haven, CT. 2003 – 2014
Quality Control Tech. II
 Reviewed Product document ensuring correctness of Bill of Material (BOM)
 Verified calibration of machine and devices prior to production start up
 Ensured machine settings matched set parameters and within acceptable range
 Performed SPC according to company SOP protocols
 Partnered with engineers and manufacturing operators to ensure product capability within limits
 Ensured double verification with manufacturing for correctness of final counts
 Segregated failed products for evaluation and decision to scrap, cull, or rework
 Verified SPC charts and trace document to meet quality specifications
Tyco Healthcare / US Surgical, North Haven, CT. 1991 – 2003
Machine Operator
 Operated Product Packaging Machine (CP-2 & Mahaffy Klockners)
 Performed SPC (Statistical Process Control) testing
 Documented and reported on production
H & R Block, West Haven, CT (Seasonal), 1995 – /2011
Income Tax Preparer
 Prepared Individual and Business Income Tax Returns
General Auditing Office Republic of Liberia (R.L)

2. Deputy Auditor General
Education/Training:
. Central Connecticut State University New Britain, CT 2016
Lean Manufacturing Program, ISO 9001, and 13485, Internal Auditor,
Root Cause Analysis, 21st Century Leadership, Six Sigma Black Belt
 Gateway Community Technical Collage
Certificate in Precision Manufacturing and SPC
University of New Haven, West Haven, CT.
 MBA with concentration in MIS
University of Liberia, Monrovia, Liberia
 BBA Business Administration / Accounting
Interests  Love Singing, Sewing and Computers
References  References are available on request.