Quality Assurance Project Manager

Lori Orlikowski, CSQE

612-***-**** **************@*****.*** linkedin.com/in/loriorlikowski

Accomplished IT Project Manager & Quality Management Expert

Professional Highlights

Technical Project Manager/Analyst, Abbott, Abbott Park, IL 60064 2023 - 2024

●Led the computer system validation (CSV) of Slack (SaaS) and 20+ critical tools for the BHS organization, ensuring compliance with SDLC methodologies, project scope, and quality standards to support Abbott product development in compliance with GxP standards.

●Managed third-party vendor team (Salesforce) in project planning, execution, and risk management for the migration, implementation, and integration of Slack, guaranteeing seamless adoption and compliance.

●Supported the validation of automated testing tools for mobile devices (Android/iOS), ensuring the reliability, regulatory compliance, and quality assurance of the Lingo product.

●Developed and delivered concise weekly project reports to stakeholders, covering status updates, key milestones, risk assessments, and issue resolution strategies. These reports enabled clear alignment and proactive decision-making, contributing to on-time delivery across 90% of project phases.

●Ensured regulatory and corporate compliance with company policies and risk mitigation strategies, adhering to industry best practices, quality assurance frameworks, and governance standards following Quality Management Standards (QMS).

●Gather and document technical requirements, facilitating functional specifications, user stories, technical requirements and acceptance criteria to support seamless system development, integration, and validation within a combination of Waterfall and Agile methodologies.

●Led offshore team management and resource coordination for a high-impact SAP data migration project, ensuring project execution, risk assessment, data integrity, minimal downtime, and adherence to project timelines.

Principal Consultant/Design Assurance Engineer, Boston Scientific, Inc. Maple Grove MN 2020 - 2022

●Mentored a team of Systems Verification Engineers on software validation and verification for medical device testing, overseeing the creation of a Quality Project Tracking Plan and updates to risk management documentation.

●Validated cybersecurity tools including Wireshark, Npcap, Nmap, Postman, and Lantap to ensure compliance with security and performance standards.

●Proficient in Risk Management and SDLC Documentation, with a proven track record in conducting comprehensive risk assessments, developing mitigation plans, and tracking compliance across cross functional teams. Experienced in aligning risk management strategies with regulatory requirements, resulting in zero major findings during internal and external audits.

●Successfully integrated Agile iterative cycles and Waterfall phase-gate reviews to support both structured and adaptive development processes.

●Matrix Cross Functional Collaboration: Partnered effectively with engineering, quality assurance, regulatory affairs, and product management teams to drive project success.

Technical Project Manager/Analyst, Abbott, St Paul MN 2019 - 2020

●Mentored a team of Systems Verification Engineers in software validation and verification for robotic medical device testing software, ensuring adherence to Quality Management System (QMS) standards and regulatory requirements.

●Provided technical guidance on medical device verification robotics, proposing optimized technical architectures to engineers as needed.

●Led and completed 10 system verifications, ensuring compliance with industry standards, risk management protocols, and regulatory guidelines.

●Developed and executed the SDLC project plan, collaborating with stakeholders to align project objectives, timelines, and deliverables.

●Monitored and enforced compliance with company policies, federal/country regulations, and industry specific standards to maintain regulatory integrity and operational excellence.

Director Program Management, Ready Credit Corporation, Eden Prairie MN 2013 - 2019

I led the end-to-end project lifecycle for the design, implementation, and execution of complex transit payment system conversions, transitioning from coin fare to a contactless, reloadable chip card system. I managed scope, budgeting, risk mitigation, stakeholder communication, and vendor coordination to ensure seamless deployment across 2,000 retail outlets. Additionally, I enforced regulatory compliance, quality assurance, and system integration best practices, ensuring adherence standards and industry regulations. For both http://www.septa.org/key/ and https://myhopcard.com/home

•Primary responsibility - Defined, designed, consolidated and maintained 11 individual retail systems into one large fully integrated retail eco-system with 2,000 locations. Facilitated SDK API integrations with all 11 payment industry systems. Performed integrations testing.

•Led 13 remote teams spanning six time zones from inception, system architecture development execution, continuous improvement and change management throughout both multi-year projects.

•Critical Financial Accuracy - Funds settlement between the retailers and the transit agencies to the penny.

•Websites - Developed two websites: Users to check card balances and transition history, and retailers to order media.

•Call Centers – Developed two call centers: Customer service questions by the transit user, and a center

for retailers.

•Foster and manage stakeholder relationships by developing and maintaining productive collaborations with business owners, project sponsors, business analysts, solution architects, vendors, and business users, ensuring alignment with project objectives and business goals.

•Oversee supplier performance and contract compliance, implementing risk management strategies and performance monitoring to ensure adherence to contractual obligations, service level agreements (SLAs), and project timelines.

•Identify, track, and resolve project issues by proactively engaging with project teams and senior management, utilizing issue management frameworks, risk mitigation strategies, and escalation processes to keep projects on schedule and within scope.

Project Manager/Software Quality Engineer, Boston Scientific, Inc. Maple Grove MN 2005 - 2012

●Led the full project lifecycle for the identification, implementation, and validation of risk management software, including selection, assessment, procurement, installation, configuration, integration, and compliance validation CSV, certifying alignment with software quality assurance (SQA) best practices.

●Managed risk management, design controls, requirements tracing, and data mining activities within the BSCI Global Quality System, ensuring regulatory compliance and adherence to quality management system (QMS) standards.

●Oversaw software quality and compliance for key systems, including Relex, Cognition Cockpit, Design Expert, Goldfire, Peripheral Controls, and Battery Life System, ensuring operational effectiveness, risk mitigation, and adherence to industry regulations.

Software Quality Engineer, EXB Solutions, Inc. Minneapolis MN 2004 – 2005

●Tested Airbus A380 Air Data Inertial Reference System (ADIRS) embedded software.

●Conducted test case development, defect tracking, and system integration testing to ensure compliance, safety, and reliability of avionics software. In compliance with DO-178B Level A requirements, ensuring the highest safety and reliability standards for avionics software.

●Executed rigorous verification and validation (V&V) testing.

Technical Project Manager, Aware Web Solutions Minneapolis MN 2003 - 2004

●Managed full project lifecycle, including scope definition, resource allocation, risk management, and stakeholder communication, aligning with Eli Lilly's project management methodology.

●Led the development and implementation of a customized Content Management System (CMS) to support the creation of 50+ websites for Eli Lilly Pharmaceuticals, ensuring scalability, usability, and compliance.

QMS Standards & Regulations

•21 CFR Part 11: Electronic Records, Signatures

•21 CFR Part 820 Quality System Regulation

•ISO 14971 Medical Device Risk Management

•ISO 13485: Medical Device Quality Management

•ISO 9001

•DO-178B level A and B

•Computer Systems Validation (CSV)

•HIPPA

•ISO 20022

•PCI/PII

Sarbanes Oxley

Certifications

Certified Software Quality Engineer (CSQE)

Certified Disadvantaged Business Enterprise (DBE)

Northwestern University, Evanston, IL, Cybersecurity Certification

Education

Minnesota State University, Mankato MN, Human Biology

Skills

Skilled in a range of tools, including Jira, Confluence, GitHub, VSS, MS Project, Trello, Slack, Teams, Postman, SQL, XML, JSON, AWS, Azure, Wireshark, Relex, Cognition Cockpit, Design Expert, Goldfire, GDP, GxP, CSV, V&V.

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