Stephanie Terwilliger Email & Phone Number

Responsible for administration of the NuScale Safeguards (SGI) Program, oversight of Regulatory Affairs work processes, and Licensing regulatory requirements management Program.

Corvallis, Oregon, United States

Supporting licensing activities related to development of NuScale Small Modular Reactor (SMR) and the NuScale standard design approval application.• Supervisory responsibility for a team of Licensing Engineers charged with SDAA submittal and NRC review support.• Team areas of responsibility include FSAR Chapter 1 (General Description of Plant), 3.1/3.2 (GDC and SSC Classification), 13 (Conduct of Operations), 14 (ITAAC and ITP), 17 (Quality and Reliability Assurance), 18 (Human Factors Engineering), and Section 19.3 (Regulatory Treatment of Nonsafety Systems).

Corvallis, Oregon Area

Supporting the Regulatory Affairs/Licensing group in continuing compliance with Nuclear Regulatory Commission requirements for NuScale’s design certification and standardized design projects. • Supporting licensing activities related to development of NuScale Small Modular Reactor (SMR) and the NuScale standard design approval application.• Primary responsibility for FSAR Chapter 17 (Quality and Reliability Assurance) and Chapter 19.3 (Regulatory Treatment of Nonsafety Systems).• Serving as licensing representative on the ISO 9001:2015 implementation team.• Responsible for maintenance of the licensing department procedure set, including initiating changes to minimize duplication, create a functional hierarchy, and make updates as processes evolve.• Performing support assignments including authoring condition evaluations and department assessments, review and analysis of new/revised regulatory requirements, and supporting communication and problem-solving within the licensing department and with external departments.

Corvallis, Oregon Area

• Responsible for all aspects of Korvis’ Quality Management System, which encompasses requirements for contract manufacturing of a wide variety of automated products under ISO 9001, ISO 13485, and FDA 21 CFR Part 820.• Owner of all QMS processes, including CAPA and associated Root Cause analysis, Customer Complaints, Vendor Management, Incoming Inspection, Nonconforming Materials/RMA, Deviations, and ECOs.• Designated Management Representative for all external (FDA, ISO, and customer) audits. • Successfully led Korvis through the company’s first site FDA inspection. • Responsible for day-to-day supervision of one QA resource.

Corvallis, Oregon Area

Responsible for day-to-day maintenance of the Korvis Quality Management System, compliant with ISO 9001:2015, ISO 13485:2016, and FDA 21 CFR Part 820. • Successfully implemented Korvis’ transition from ISO 9001:2008 and ISO 13485:2003 to ISO 9001:2015 and ISO 13485:2016, including gap analysis, planning, execution and participation in subsequent Phase I and Phase II audits.• Managed adherence to process requirements for key QMS systems, including document control and engineering change orders, nonconforming materials, process deviation, advisory notices, validations, expired materials, corrective/preventive actions, ESD, and external documents, and all third-party and internal calibration activities for the site. • Participated in all external regulatory audits for ISO 9001 and ISO 13485 compliance and routine TUV factory safety inspections for NRTL compliance. • Responsible for creation, approval, maintenance, and distribution of QMS documentation, and managing associated training for all personnel. • Routinely performed audits of the QMS as an Internal Auditor.

Corvallis, Oregon Area

• Led a production line for a Class II automated genetic analysis ISO 13485-compliant medical device product from design-to manufacturing-transfer and initial prototype builds, to mature product delivery under rigorous schedules. • Responsible for all aspects of the life of this product, including: development of test stations and methods, generation of build and test procedures, development of incoming inspection criteria, technician training, regulatory safety (NRTL) and EMC certification, product quality trending, product risk assessment, engineering change orders, coordination of all validation activities including protocols/reports, resolution of field issues and RMA’s, review and delivery of final product documentation to customer.• Responsibility for ensuring that the product line conforms to all Korvis Quality Management System (QMS) requirements. • Coordinated between Quality, Purchasing, Manufacturing, and customer representatives to ensure that product delivery and quality commitments are met.

• Responsible for the quality system for the Advanced and Specialty Products Division (ASP), an emerging business unit focused on FDA-regulated medical devices and pharmaceuticals. • Served on a team charged with aligning a product manufacturing process with FDA requirements. Team successfully met milestones, resulting in the on-time manufacture of critical product batches. • Wrote procedures for operation, cleaning, and usage of new equipment; developed and executed validation protocols for new equipment and processes; and assisted with resolution of product quality issues.

Corvallis, Oregon Area

• Taught an upper-division engineering CAD course using ProEngineer software.

Beaverton, Oregon

• Represented validation activities in a critical FDA medical device product approval audit.• Served as team leader for process/product non-conformance investigations, and issued final investigation reports. • Coordinated all validation activities for two product lines, created validation documents, scheduled activities on- and off-site, developed quality systems/procedures. Maintained the facility calibration program.

Santa Clara, Ca

• Responsible for quality operations for a newly acquired in-vitro diagnostics reagents manufacturing group. • As team leader and primary validation engineer, coordinated start-up and validation of a new reagent manufacturing facility which achieved FDA approval. • Implemented a site-wide validation program, identified critical processes, and coordinated validation activities. • Led a team of three contract validation engineers. Represented validation during FDA and Abbott Corporate Audits.• Received ISO 9001 Lead Auditor certification and served on the qualification team which resulted in site ISO 9001 registration.

Palo Alto, Ca

• Supported start-up and validation of an FDA 21 CFR Part 211 compliant, aseptic Class 100 manufacturing facility for clinical parenteral drug supplies. • Coordinated all QA cleaning validation activities for pharmaceutical manufacturing equipment, monitored equipment validation status and facilitated validation effort among QC, QA, and manufacturing groups. • Responsible for environmental monitoring of a sterile parenteral manufacturing facility, including data analysis and trending.• Developed procedures for clinical manufacturing, investigated product/process deviations, product non-conformances, and customer complaints received from clinical study sites.

Bs, Mechanical Engineering

Activities and Societies: Pi Tau Sigma

Ba, Microbiology

Lmt (In-Process), Massage Therapy/Therapeutic Massage