Suzanna Ward Lee

About Suzanna Ward Lee

Senior Medical Device Quality Systems Consultant with a proven track record of driving compliance, process excellence, and regulatory readiness across startups and Fortune 500 organizations. Expert in designing and optimizing QMS frameworks aligned with ISO 13485, EU MDR, and FDA QSR. Known for building high-impact cross-functional partnerships and delivering results on complex, high-stakes initiatives. Committed to leading with precision, integrity, and strategic foresight.INTERNATIONAL EXPERTISE IN:Quality Assurance and Regulatory Affairs: Extensive expertise in conducting compliance, quality, and regulatory gap assessments across global frameworks including ISO 13485:2016, ISO 14971, FDA regulations (21 CFR Part 820 & 803), EU MDR, UKCA, Swiss Medical Device Ordinance, and the Eurasian Economic Union (EAEU).Proven success in internal and external audit preparation, experienced in working with major notified bodies including TÜV, BSI, and DEKRA, Skilled in technical writing, quality planning, and field actions/recalls execution, and post-market surveillance, with specialized focus on complaint handling, FDA MDR (21 CFR Part 820 & 803) submissions, and risk management (FMEA).Consistent performance in quality system optimization and procedures, and remediation leadership activities and sustaining global regulatory compliance and audit readiness. Recognized for leading integration and process improvement initiatives, acquisition and integration support, and supporting talent management and driving QMS excellence and regulatory readiness across the product lifecycle. Project Management and Leadership: Proven expertise in full lifecycle program and budget management, including vendor selection, process optimization, and effective stakeholder communication. Recognized for conflict resolution, consensus building, and leading cross-functional initiatives across global teams.Demonstrated leadership in international team supervision, including recruiting, onboarding, training, and performance evaluations. Successfully led organizational transitions, acquisition integrations, and change management efforts across global clinical and regulatory functions.

Experience

1. Senior Quality Systems Consultant

   Johnson & Johnson

   Apr 2017 — Present · Lake Forest, IL, US

   Held concurrent roles as SME, project lead, and documentation strategist, providing expert guidance, managing high-impact initiatives, and authoring knowledge transfer materials to scale team capabilities.Chosen to serve on the acquisition and integration team in 2023 for Abiomed, Inc, driving the successful transition of new business. Led the development of strategic action and quality plans, oversaw large-scale gap assessments, and identified key process improvements to enhance compliance and operational efficiency.Championed regulatory transformation across Johnson & Johnson’s medical device unit by designing and executing a scalable EU MDR Article 15 compliance strategy; successfully established the PRRC function enterprise-wide, including post-acquisition integration, ensuring end-to-end conformity with evolving EU regulatory requirements.Extensive experience conducting regulatory and quality gap assessments, 180+ procedure revisions and process creation and changes. Authored and optimized critical quality system documentation—including quality plans, interim assessments, and final reports—across Johnson & Johnson’s medical device organization; collaborated with senior leadership to ensure alignment with global quality standards and EU MDR requirementsLed 11 Quality Management System (QMS) workstreams across J&J’s global surgical portfolio, driving successful ISO 13485:2016 and EU MDR audit readiness with zero non-conformances.Implemented a risk-based framework aligned with ISO 14971, and introduced a standardized job description procedure to support scalable QMS compliance.Recognized for cross-functional leadership: extended multiple times and appointed to the Emerging Standards & Regulations Implementation team (2022), then selected in 2023 to support acquisition integration efforts for Abiomed under MDR and UKCA transition planning.Placed by Oxford Global Resources.

Education

• University of Oregon

  BA in Romance Languages, Italian, French, Business Administration

  1996 — 2000

• University of Oregon

  Bachelor of Arts - BA, Romance Languages, Literatures, and Linguistics

Skills

• Technology Transfer
• Validation
• Mdr
• Tuv
• Corrective and Preventive Action (Capa)
• Fmea
• Regulatory Submissions
• Talent Management
• Quality Control
• Gmp
• Post Market Surveillance
• Software Documentation
• Biotechnology
• 21 Cfr Part 11
• U.s. Food and Drug Administration (Fda)
• Design Control
• Iso 13485
• Cross-Functional Team Leadership
• Quality Auditing
• Training
• Regulatory Affairs
• Process Improvement
• Quality System
• V&V
• Risk Management
• Clinical Trials
• Iso
• Pharmaceutical Industry
• Sop
• Fda
• Recalls
• Auditing
• Customer Service
• Medical Devices
• Capa
• Complaint Management
• Change Control
• Quality Assurance