Quality Engineer

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Shannon McCullough

Phone: 412-***-**** Email: ********************@*****.*** Experience Highlights:

● Experienced in QMS, CAPA facilitation, DHF/DMR, Complaint Investigation, Risk Analysis, Health Hazard Analysis, Gap Analysis

● Support CAPAs from inception to closure

● Execute Root Cause Analysis with cross-functional teams

● 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 document control and routing documents

● Leader in writing SOPs, Effectiveness Checks, and UAT test scripts

● Experienced in Quality Management Systems and Federal Regulations

● Knowledgeable in FDA guidelines, MDR EU, DHF, Clinical Trials, GxP, audits, regulations, CTLC, SDLC, TLC, PDLC, GMP, GDP, IQ/OQ/PQ

● Created/Maintained Master Validation Plans, process improvements, change control orders, CSV Validation, Electronic Data Management

● Experienced in qualification validation, report data, and user functionality

● 21 CRF Part 11, IEC 62304, ISO 13485/10993/14971/62304

● Experienced working with Stakeholders, Auditors, Global Teams, and End Users

● Collaboration Skills, Meeting Facilitation, and requirement analysis

● Rally, SharePoint, Trackwise, Jira, Jenkins, SharePoint, TFS, MS Office/365, VSS, Workday, reporting tools, Alfresco, Cockpit, Windchill, Teams, Zoom Professional Experience:

Philips

QA Assurance Engineer Consultant (09/24 – 12/24)

● Protocol and effectiveness check validation

● Complaint investigation and CAPA Facilitation

● Review Design History Files and update due to CAPA outcomes

● Client support and tracking recall activities

● Served as Project Manager on CAPA activities

● Creating and maintaining SOPS and Work Instructions in eQMS

● Executed Root Cause Analysis Investigations using various tools (5 Whys, Fishbone)

● Document Control & Audit Support

Freelance: Audit & Testing consulting (08/23-09/24)

● Audit support

● Testing and documentation

● Process improvements

Smith & Nephew

Quality Assurance Engineer Consultant (02/21 – 08/22)

● Led QE efforts for Design History File remediation for several acquired orthopedic products

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3/20/2025 Shannon McCullough

● Created processes for Design History File transfers in the orthopedic division

● Routed more than 10,000 documents for acquired products

● Assisted in Risk Management Plans and Post Market Surveillance activities

● Verified product requirements and new testing tools

● Assisted in Regulatory and Compliance Tasks, Design Control Validation, and CAPA investigation

● Authored requirements, SOPs, Milestone presentations, process improvement initiatives, test cases, Milestone Reviews, Risk Documents, and QMS documentation

Mortgage Connect

QA Lead Consultant (01/20 – 03/20)

● Successfully established product requirements testing policies, procedures, and IT onboarding materials, and Salesforce training documents ERT

Lead Quality Control & Quality Assurance Engineer (04/04 – 06/19)

● Reviewed Data from the product software to verify compliance issues

● CAPA, Gap Analysis and root cause investigations

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

● Led all quality efforts for medical device communication with Android and IOS

● Worked with Medtronic to ensure implanted medical devices communicated with ERT’s clinical trial software

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

● Led Offshore & Stakeholder communications

● Created and maintained all SOPS for product delivery teams

● Develop and maintain CSV deliverables for client technical files

● Executed Root Cause Analysis and CAPA Meetings

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

● Verification and Validation activities

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

● Coordinated projects, delegated responsibilities, and wrote test reports. 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 Associate's Degree: Computer Science

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