Medtronic

Senior Quality Systems Program Manager

Support various Operation Units (OUs) within the Neuroscience portfolio by leading Field Corrective Actions, support FCA audits, and other post-market surveillance activities via coordination with various stakeholders globally. Portfolios of the OUs include:
•	Neuroscience
•	Medical Surgical
•	Cardiovascular

Among other responsibilities, identify and develop process improvements to increase effectiveness, efficiency, and compliance. Project(s) include:

• Enterprise Customer Quality Recall QMS Transformation Project
- Support as the FCA planning team lead, the Enterprise Customer Quality (CQ), a corporate initiative to create a simplified and streamlined QMS Governance and shared processes across the company to support the new Operating Model (re-org), while maintaining compliance, reducing the burden, and improving effectiveness and speed.

• Enterprise Customer Quality Recalls Electronic Storage Repository Project
- To create a standard single shared electronic FCA document repository for storing all FCA files.
- Create a Shared - Enterprise FCA electronic repository and folder structure for all FCA files across portfolios. 
- Discontinuation and Migration of hard-copy FCA files (FCA Books).

Quality Systems/Compliance Program Manager - Neuroscience, CV, and Medical Surgical Portfolios

•	Primary Global PHO/FCA coordinator/contact (SME)
•	Collaborate globally and cross-functionally to execute on product hold orders, which may involve the following functions: Customer Service, Post Market Quality, Distribution Centers, Manufacturing Facilities
•	Develop, establish, and maintain quality assurance programs, policies, processes, procedures, and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure lasting customer satisfaction. 
•	Provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to assure compliance. 
•	Serve as a liaison between the company and the various governmental agencies. 
•       Work directly with operating entities to ensure that inspections, statistical process control analyses, and audits are conducted continuingly as specified to enforce requirements and meet specifications.

Quality Systems Specialist - Post Market Risk Management

Medtronic Brain and Spine Therapies

• Primary Global PHO/FCA coordinator/contact (SME)
• Collaborate globally and cross-functionally to execute on product hold orders, which may involve the following functions: Customer Service, Post Market Quality, Distribution Centers, Manufacturing Facilities
• Serve as a liaison between the company and the various governmental agencies.

Associate Quality Systems Specialist - Post Market Risk Management

Medtronic Spine & Biologics

•	Processed all order types: stocking orders, sets, consignments, loaners, credits, and drop-shipments from the Memphis facility. Issued appropriate debit/credit for product movement between OUS markets. 
•	Processed all documentation that was pertinent to Letters of Credit, Temporary Imports, and Carnets.  Understood harmonize tariffs and how to determine the tariff by utilizing the Schedule B Commodity Reference Manual. 
•	Worked closely with the Regulatory department to coordinate documentation and maintain compliance. 
•	Promoted Touchless Order Production through Electronic Channels, such as MSTAR, GHX, and EDI.

Principle Customer Care Rep. - Service Innovation Group (SIG)/Automation Advocate (SME) 

•	Trained/developed team members to operate independently to accomplish team goals
•	Oversaw daily production to ensure work is processed within established timeframes; coordinated with other Leads to align DC staff.
•	Functioned as primary subject matter expert (SME) for receiving processes.

Distribution Group Lead IV, Memphis Order Processing

Domestic Order Processor II

I am a Quality Systems and Compliance Subject Matter Expert with a passion for enhancing and advocating quality best practices and strategic marketing. I have over 10 years of experience in the Medical Device and Technology industry, where I have honed my skills in distribution and manufacturing procedures, customer service, quality systems, and compliance. Additionally, I have a strong background in strategic marketing, specifically in crafting and executing marketing plans for both large-scale corporations and non-profit organizations.

In my free time, I love volunteering with children, engaging in marketing projects, spending quality time with family, and exploring new places through travel.

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