Quality Assurance Medical Device

Sharon Miles

*** ******** **** #****

Charlotte, NC 28217

Phone: 336-***-****

Email: *********@*****.***

Summary of skills

Strong knowledge of highly regulated medical device industry (FDA, MDD), with high level of

experience in Customer Service, Quality Assurance and Regulatory Affairs. Communicates well with

all levels of organization and industry. Highly adept in organizing and presenting information for

targeted audience. Self-motivated leader that works well with cross-functional teams and skilled

technical writer/reviewer. Interested in either managing or non-manager positions.

Work Experience

2011 to 2013: Regulatory Communications Manager - Cook Medical, Inc. (Winston-Salem, NC)

• Managing staff with a focus on medical device complaint documentation, global adverse

event reporting, recalls and communication with global regulatory authorities

• Participating in documentation process for Cook sponsored clinical trials, working directly

with Cook personnel and investigation teams.

• Responsible for training direct reports on updates to quality system and procedures.

• Responsible for preparing, reviewing and approving technical documentation for submission

to regulatory authorities, including FDA, for adverse event reports and product recalls.

• Member of Cook Medical Global Task Force - cross-functional team assisting all Cook

manufacturers with adverse event reporting decisions, responses to regulatory authorities,

and field action/recalls

• Organizing and presenting adverse event and recall information to all levels of management

• Providing Regulatory Affairs with complaint and adverse event data for global registrations

• Assisting Regulatory Affairs with Japanese SOGO review project

• Point of contact for company counsel related to complaints involving litigation

• Leadership role in third party external audits involving US FDA and TUV America

2004 to 2011: Customer Quality Assurance Manager - Cook Medical, Inc. (Winston-Salem,

NC)

• Managed staff responsible for all activities related to complaint documentation, investigation,

health hazard evaluation (HHE), global adverse event reporting and recalls.

• Responsible for preparing, reviewing and approving technical documentation for submission

to regulatory authorities, including FDA, for adverse event reports and product recalls.

• Responsible for training new Sales and Marketing personnel for their role in complaint

processing.

• Responsible for organizing and presenting complaint, adverse event and recall information to

Quality Review Board (QRB), Material Review Board (MRB) and all levels of management

• Developed process for health hazard evaluations (HHE) and shipping holds

• Performed root cause analysis and served as CAPA team leader

• Worked with Information Technology during implementation and validation of new complaint

software TrackWise® (by Sparta Systems), transitioned to paperless system saving time and

cost

• Point of contact for company counsel related to complaints involving litigation

• Leadership role in third party external audits involving US FDA and TUV America

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2001 to 2004: Quality Engineer - Cook Medical, Inc. (Winston-Salem, NC)

• Conducted medical device complaint investigations, including laboratory evaluations, review

of various technical documentation and determination of corrective action

• Communicated directly with physicians and nurses regarding product complaints

• Leadership role in execution of field actions/recalls

• Internal Auditor (2002-2004); ISO 13485, US FDA Code of Federal Regulations, MDD

• Participated in root cause analysis and served as CAPA team member

• Participated in third party external audits involving US FDA and TUV America

Education

University of Tennessee - B.S. Industrial Engineering, 2001

• Senior Project: LeConte Medical Center (Sevierville, TN)

• Internships:

o Nortel Networks, Inc. (Nashville, TN)

o United States Postal Service (Knoxville, TN)

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