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.

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.

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.
• 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.
• 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.
• 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.
• 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