Shannon McCullough

Phone: 412-***-**** Email: ad2cvx@r.postjobfree.com

Summary: I am an experienced Quality Engineer with an extensive background in regulated environments, testing, auditing, protocol validation, process improvements, business user interaction, and team leadership. I am eager to join a medical device company where I can learn new technologies and skillsets to provide you with the optimal skillset to be successful.

Experience Highlights:

Experience with Phase 1,2,3 clinical trials and medical devices

Led multiple QA, Dev, and Support teams (manual, automated, onshore and offshore) in high-paced agile, iterative, and waterfall environments

Served as an escalation point and subject matter expert for new and legacy products as well as for operations teams resolving issues

Key contributor in verifying workflows and protocols meet quality criteria

Knowledgeable in Input/Outputs, Risk Factors, compliance testing, Verification/Validation, QMS Implementation

Assessing software to ensure all standards are met and risks identified

Authored test plans, SOPs, functional/system requirements, defects, test status reports, test strategies, test traces, standard operating procedures, work instructions, testing processes, audit reports, risk documents, QMS repositories

Experienced in Quality Management Systems and Medical Device Life Cycle

Knowledgeable in FDA guidelines, EU, DHF, Clinical Trials, GxP, audits, regulations, CTLC, SDLC, TLC, PDLC, MDR, cGMP, Risk Assessments

Created/Maintained Master Validation Plans, process improvements, and change control orders, CSV Validation

Working knowledge of 21 CRF Part 11, ISO 13485/10993/14971/62304.

Team/resource planning, point scaling, process improvement initiatives, holding meetings, stakeholder interaction, escalation management

Participated in risk assessments, CAPAs, RCAs, FEMA, gap analysis, procedure guidelines, defect triages, training, cross-functional team, milestone meetings

Rally, Jira, Jenkins, SharePoint, TFS, MS Office/365, VSS, Workday, Reporting tools, Alfresco, Cockpit, Windchill, Teams, Zoom, Browser tools

Professional Experience:

Orrick, Herrington & Sutcliffe LLP Remote

QA Data Analyst Consultant (Digital Marketing, (04/23-06/23)

Data Cleanup and verification

Data Migrations, application testing, and support for Marketing applications

Smith & Nephew Remote

QA Engineer Consultant (Medical Device Manufacturer, (02/21 – 08/22)

Led Integration teams to ensure acquired EU medical products met company and US compliance standards within the medical device industry

Successfully led salesforce data migration projects by defining requirements and validating transmission from an acquired companies’ data repository to Smith & Nephew’s data hub

Created Risk Management Plans, followed FMEA process guidelines

Assisted in QMS, Regulatory and Compliance Tasks

Tested orthopedic surgical instruments, assisted surgical units, SiMD, SaMD

Safety and process validation, risk factor reporting, complaint investigations

Created processes to transfer technical documentation (DHF) and data from acquired products and tested process and data transfers

Contributed and led concurrent projects of multiple levels of complexity

Trained interns and created a workflow process to transfer Design History Files

Verifying protocols are followed and objective evidence supports criteria submitted

Mortgage Connect Pittsburgh, PA

QA Lead Consultant (Real Estate Financing, 01/20 – 03/20)

Successfully established product requirements testing policies, procedures, and onboarding materials and salesforce policies

ERT Pittsburgh, PA

Lead Quality Control Test Engineer (Pharmaceuticals, clinical trials, 04/04 – 06/19)

Worked as BA and QA Lead on Web portals that housed clinical data for clients and patients

Contributed to QMS implementation and tracked the training process of product employees

Served as a subject matter expert in Audits and new product training

Led all quality efforts for medical device communication with Android and IOS platforms (glucose meters, PEF readers, and brain stimulators)

Ensured CSV packages adhered to FDA Compliance rules from all departments to submit data to clients for approval

Verified all department deliverables were met via automated and manual systems

Verified communication between medical devices and Site Web portals

Setup testing environments for internal teams and verify configuration control processes

Worked with server-side/client-side apps, Cloud, IOS, Android, Web Clinical Trials, Pharmaceuticals, FDA regulations, GDP

Quality Control Test Coordinator (07/05 – 04/08)

Coordinated projects, delegated responsibilities, and wrote test reports.

Tested Web Reports and Production installation packages

Quality Control Tester (Pharmaceuticals, clinical trials, 04/04 – 11/04)

Authored and executed test plans, reports, and defect analyses for clinical trials

Education

International Academy of Design and Technology Associates Degree: Computer Science

Computer Learning Center MCSE training

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