Michaela Moore Email & Phone Number

Leader of the global GEHC production and process controls quality system and strategy, employing lean methodologies to ensure the quality system processes and tools enable nimble and compliant process control. Drives high-priority, global changes that are critical to quality and compliance, across all sites and regions.

Madison, Wisconsin, United States

• Interpret regulatory changes and communicate regulatory requirements to business teams to assure continued compliance.• Develop and execute regulatory strategy for Class II devices.• Manage global pre-market regulatory submissions for license approvals, re-registrations and renewals for life-supporting, life-sustaining anesthesia machine medical device products.• Supported as regulatory subject matter expert for notified body and regulator audits.• Championed transition into Destination Matrices in Torus tool.• China labeling Subject Matter Expert for multiple modalities.• Provided urgent support for cybersecurity post-market concerns and recall.• Mentored and trained junior regulatory affairs team members on regulatory key competencies, responsibilities, and tools.• Team player and adaptable to cover other products and projects as needed.• Transferred manufacturing of ventilators during COVID pandemic in a quarter of the time normally allocated for such transfers and navigated global emergency use authorizations.• Continued to be a subject matter expert in site transfers and collaborated on creation of guidance for future transfers.• Lead First Responder to coordinate procedures and processes.

Wauwatosa, Wisconsin, United States

• Led team of 4 regulatory personnel in site closure and transfer of physical and legal manufacturing. • Pioneered determination of regulatory requirements as one of the first major transfers at GE.• Developed, authored, and executed regulatory strategy and cross-functional labeling strategy.• Coordinated and led the establishment of notified body audit and certificates at 3 sites.• Presented monthly to leadership regarding transfer progress.• Successfully registered MIC product portfolio globally with no unexpected gaps in market.• Subject Matter Expert for additional transfers – coordinated and developed proposal to leadership for launch of Tower Transfer to Research Park.• Energizer Team member to promote employee satisfaction at the Madison site.

Madison, Wisconsin, United States

• Led cross-functional New Product Introduction teams in two modalities.• Collaborated cross-functionally to prepare and facilitate content for LCS QMR and monthly reviews to leadership, by identifying critical metrics and tracking action status.• Lead Internal Auditor for site audits spanning entire QMS.• Manage questions for backroom FDA support in 2 audits.• Recruiter for Quality Regulatory Leadership Program.

Madison, Wisconsin, United States

• Developed and executed strategy for inspection and test documents.• Lead and executed simplification project in nonconforming material reports.• Led compliance of recall of 75k Tec6+ vaporizer.• Streamlined hold process by identifying redundant work.• Daily line support of concessions, deviations, changes, validations, qualifications and holds.• Developed and represented alumni QRLP as first ever QRLP Alumni Liaison Quality & Regulatory Leadership Program.

Waukesha, Wisconsin, United States

• Central Design Controls Team – Established lifeline calls for global audience.• Quality Engineer in Product Process Controls at ARC Madison – Improved defect trending.• Quality Engineer in Production Process Controls at Xray Waukesha - Completed update to Concession and Deviation Work Instruction and facilitated global training.• Trained as Lean Six Sigma Black Belt and completed project in manufacturing defects.• EDGE (Early Development at GE) Community Service Chair.• Co-Led planning of Quality Regulatory picnic.

Madison, Wisconsin, United States

• Designed and created a device to aid individuals with movement related disabilities in activities such as eating, painting, and welding.• Authored thesis to document mechanical findings in this product design.

Madison, Wisconsin, United States

• Planned and prepared lesson plans for College Algebra three times a week.• Facilitated two classes of 30 students as the only teacher the students interacted with.• Used variety of learning modalities and support materials to facilitate learning process.

Urbana, Illinois, United States

• Analyzed gait of Labrador Retrievers and collaborated with veterinary expertise to determine predisposition to ligament deficiency.• Investigated upper extremity movement in wheelchair users.• Developed and presented laboratory project overviews in symposium.

Urbana, Illinois, United States

• Worked with 3 other students to modify and improve quality controls for Quantum Foods.• Researched and implemented alternate methods to measure pH, salinity and temperature.• Conducted analysis and compose in-depth report.

Masters, Mechanical Engineering (Biomedical Product Design Concentration)

Bachelors, General Engineering (Biomechanics)

Activities and Societies: Alpha Omega Epsilon Engineering Sorority, Gamma Epsilon Honor Society, LEADS Resident Advisor, Vis-A-Vis.

Education record

Studied abroad in Italy and took language and culture class in Italian.